3 Adverse Event Reporting Jobs nearby Sonipat

Role Overview: As a Pharmacovigilance Specialist at Putnam Associates, you will play a crucial role in supporting the execution and management of pharmacovigilance (PV) compliance and reporting processes. Your primary responsibility will be to provide direct assistance to case teams and focus on enhancing Putnam's pharmacovigilance and compliance procedures. You will be an integral part of the Consulting Operations and Support team, contributing to the overall success of Putnam's consulting endeavors. Key Responsibilities: - Provide support to the PV Manager by assisting in case management activities to ensure that Adverse Event (AE) information is processed in adherence to documented timelines and quality standards. - Assist the PV Manager in preparing for audits and organizing data efficiently. - Monitor the implementation of processes specified in client PV agreements and safety management plans. - Conduct training sessions for consulting staff on new and updated client PV processes. - Offer guidance and assistance in the review and submission of Adverse Events (AE)/Serious Adverse Events (SAE) reconciliation and other quality requirements. - Manage, track, and coordinate compliance training for consulting team members working with various clients. - Provide necessary content guidance for all safety documentation and support in maintaining compliance. - Train third-party vendors on clients" PV compliance standards and assist consultants in resolving technical issues with PV client platforms. - Address various client and internal quality control questions promptly and efficiently. - Collaborate in developing streamlined processes to ensure adherence to client PVAs. - Assist in expediting market research fielding approval with clients. - Facilitate new hire onboarding PV training and maintain documentation of completion. - Contribute to creating/revising quality and compliance policies, SOPs, processes, and best practices as required. - Proactively identify and mitigate compliance risks in partnership with stakeholders and escalate critical compliance risks to the PV Manager. Qualifications Required: - 2-5 years of relevant experience in pharmacovigilance or a related field. - Bachelor's degree in Business, Marketing, or Social Sciences preferred. - Proficiency in working with Excel, PowerPoint, and MS Word. - Strong attention to detail, exceptional organizational skills, and outstanding project management abilities. - Excellent analytical skills and the capability to derive business insights from data. - Ability to thrive in a fast-paced, growth-oriented environment. (Note: The company emphasizes a commitment to diversity and inclusivity, encouraging candidates to apply even if their experience does not perfectly align with every job requirement.),

As the Senior Manager / Manager of Clinical Research, you will be responsible for leading and managing clinical trials and research studies to ensure they are completed on time, within budget, and in compliance with regulatory standards. You will supervise research teams, collaborate with cross-functional departments, and provide strategic direction for clinical research activities. Key Responsibilities: - Plan, initiate, and manage clinical research projects from start to finish. - Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets. - Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards. - Provide oversight on the recruitment, enrollment, and monitoring of clinical trial subjects. - Manage relationships with clinical research organizations (CROs), investigators, and external vendors. Team Leadership: - Lead and mentor clinical research staff, ensuring they are trained and performing effectively. - Assign tasks and responsibilities to team members based on project needs. - Develop training programs and provide ongoing professional development for research teams. Regulatory Compliance: - Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications. - Monitor compliance with federal, state, and local regulations, as well as company policies. - Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards. Study Design & Protocol Development: - Work with scientific and medical teams to develop clinical trial protocols. - Ensure protocols meet study objectives, regulatory standards, and ethical guidelines. - Evaluate feasibility and risk of proposed studies. Data Management and Reporting: - Ensure data collection, monitoring, and analysis are conducted efficiently and accurately. - Review and analyze clinical trial data to ensure quality and integrity. - Prepare and present progress reports to senior leadership and stakeholders. Budget and Resource Management: - Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints. - Oversee resource allocation, including personnel, equipment, and materials. Collaboration and Communication: - Foster communication between internal teams, external partners, and key stakeholders. - Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution. - Resolve any issues related to clinical trial execution and provide solutions. Continuous Improvement: - Identify areas for process improvement in clinical trial execution and management. - Implement best practices to optimize research efficiency and compliance. Qualifications: Education: - Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred). Experience: - Experience in clinical research, with at least 2-3 years in a managerial or supervisory role. - In-depth knowledge of clinical trial management, regulatory requirements, and GCP. Skills: - Strong project management, leadership, and organizational skills. - Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders. - Proficiency in clinical research software and data management systems. - Strong problem-solving and decision-making abilities. Certifications: - Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent). Working Conditions: - Full-time, in-office or remote, with occasional travel required to clinical trial sites and partner organizations.,

As the Senior Manager of Clinical Research, you will play a crucial role in leading and managing clinical trials and research studies. Your responsibilities will include: - **Clinical Trial Management:** - Plan, initiate, and oversee clinical research projects, ensuring adherence to protocols, timelines, and budgets. - Maintain compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards. - Supervise the recruitment, enrolment, and monitoring of clinical trial subjects. - Manage relationships with clinical research organizations (CROs), investigators, and external vendors. - **Team Leadership:** - Lead and mentor clinical research staff, assigning tasks based on project needs. - Provide training programs and professional development for the research teams. - **Regulatory Compliance:** - Oversee the preparation and submission of regulatory documentation. - Monitor compliance with regulations and company policies. - Ensure timely reporting of adverse events and ethical standards. - **Study Design & Protocol Development:** - Collaborate with scientific and medical teams to develop clinical trial protocols. - Evaluate feasibility and risk of proposed studies. - **Data Management and Reporting:** - Ensure efficient data collection, monitoring, and analysis. - Review and analyze clinical trial data for quality and integrity. - Present progress reports to senior leadership and stakeholders. - **Budget and Resource Management:** - Develop and manage project budgets. - Oversee resource allocation, including personnel, equipment, and materials. - **Collaboration and Communication:** - Foster communication between internal teams, external partners, and stakeholders. - Collaborate with various departments for effective study execution. - **Continuous Improvement:** - Identify areas for process improvement in clinical trial execution. - Implement best practices for research efficiency and compliance. **Qualifications:** - **Education:** - Bachelor's degree in Life Sciences, Clinical Research, or related field (Master's or higher preferred). - **Experience:** - 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial role. - **Skills:** - Strong project management, leadership, and organizational skills. - Excellent communication and interpersonal skills. - Proficiency in clinical research software and data management systems. - Strong problem-solving and decision-making abilities. - **Certifications:** - Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred. This role offers you the opportunity to lead and manage clinical research activities effectively, ensuring compliance, quality, and efficiency in clinical trials and research studies.,

The Sales Representative role at Novartis is crucial for driving customer interactions and sales performance, serving as the primary face of the company's customer experience approach. Building strong relationships with customers and patients is key to delivering value and ensuring sales growth in a compliant and ethical manner. **Key Responsibilities:** - Develop business plans and execute related activities such as customer events, sales and marketing campaigns, and presentations to achieve set objectives. - Be accountable for meeting sales, productivity, and performance targets within specified budgets and timelines. Provide support to key accounts and hospital networks, ensuring market access support and referral networks are in place. Possess a deep understanding of specialist areas and priority products. Stay updated on product knowledge, strategy, positioning, key messages, programs, company developments, customers, and competitors. - Meet contact, coverage, and frequency targets through various communication channels. Ensure customer satisfaction and maintain excellent customer relationships. Complete reports accurately and in a timely manner. Address inquiries and complaints professionally and in line with company procedures. - Collaborate effectively with the Sales and Marketing team to achieve team and company objectives. Provide input on the optimal use of promotional funds and contribute to territory sales forecasting. - Adhere to adverse events guidelines and Code of Conduct Guidelines as outlined by Novartis. Demonstrate behavior in accordance with Novartis" code of practices. - For Managers/Leaders, take responsibility for sales planning, target setting, reporting, and understanding the team and individual account knowledge. Report technical complaints, adverse events, and special cases related to Novartis products promptly. Distribute marketing samples as required. - Achieve sales revenue and market share targets as per the plan. Manage the allocated budget for customer activities. Focus on customer satisfaction and building strong customer relationships, particularly with Key Accounts. **Role Requirements:** - Possess 3+ years of sales experience in Healthcare/Pharma or related fields, with an established network to target Customer Groups being desirable. - Experience in Cardiovascular, Diabetic, and Corporate hospitals is preferred. - Territory knowledge is essential for this role. - A science educational background is mandatory, with a degree in B.Sc or B.Pharma. - Strong communication skills are required. **Desirable Requirements:** - Experience in Cardiovascular products would be advantageous. **Why Novartis:** Novartis aims to reimagine medicine to enhance and extend people's lives, striving to become the most valued and trusted pharmaceutical company globally. It is the dedication and drive of our associates that propel us towards our goals. Join us in this mission and be a part of our journey to make a difference in the world. For any accommodation needs related to disabilities during the recruitment process or while performing job functions, please reach out to diversityandincl.india@novartis.com with your request and contact information, mentioning the job requisition number. **Benefits and Rewards:** To learn more about the benefits and rewards offered by Novartis, refer to the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards Novartis is committed to fostering an inclusive work environment and building diverse teams that reflect the patients and communities we serve. **Additional Details:** Novartis values diversity and inclusion in the workplace, aiming to create an exceptional work environment that celebrates the uniqueness of individuals and promotes collaboration among diverse teams.,

As a member of the team, you will play a crucial role in achieving exceptional business outcomes by effectively leading your team. Your responsibilities will include: - Utilizing your writing skills to craft narratives for adverse events and product complaints during intake, as well as developing customized responses for medical inquiries. - Handling customer requests through various channels such as phone, email, CRM, and chat platforms. - Identifying adverse events and product complaints during customer interactions, conducting intake procedures to generate compliant reports in accordance with EVERSANA-MICC and client SOPs. - Demonstrating knowledge of FDA post-marketing adverse event reporting regulations and safety terminology, and making informed decisions on the required information and its depth. - Coordinating processes to address product quality-related complaints, collaborating with Quality Assurance, Regulatory Affairs, and complainants as necessary. - Keeping abreast of product, therapeutic area, and client-specific requirements. - Ensuring meticulous documentation, maintaining high quality standards, and delivering exceptional customer service. - Showing a steadfast dedication to diversity, equity, and inclusion through ongoing development, modeling inclusive behaviors, and actively managing biases. In addition to the above responsibilities, you may be assigned other tasks as needed. The ideal candidate should possess the following qualifications: - Education: Pharm.D, Master of Science (MSc), B.Pharm, M.Pharm, or any other Life Sciences degree. - Experience and/or Training: Proficiency in documentation, strong verbal and written communication skills, and a solid clinical background. Fluency in spoken and written English is essential. Preferred qualifications include the same educational background and skill set as mentioned above.,

As the Head of Global Quality at our company, you will play a crucial role in leading the development and execution of quality assurance strategies aligned with our long-term goals. You will partner closely with the Chief Technical Officer (CTO) and the Leadership Team to ensure robust quality management systems, regulatory compliance, and continuous improvement in operational performance. **Key Responsibilities:** - Establish best-in-class quality goals, perform quality metrics trending, apply problem solving, system improvements to meet these target levels of quality. - Lead and manage the quality teams with oversight in operations at all manufacturing facilities with a continuous improvement focus. - Build and inspire a team of QA professionals through training, mentoring, and management in the adoption of new processes and tools. - Collaborate with business units to develop quality targets for new and existing products. - Manage quality projects and activities resulting from site consolidations and acquisitions. - Collaborate with the Quality Management System group on simplification, harmonization of quality systems, and implementation across Operating Companies. - Ensure the effectiveness of the Quality System across all manufacturing sites and Contract Manufacturing site. - Implement and follow an effective Vendor/Supplier development process. - Drive recruitment activity and assure the ongoing professional development of direct reports and the overall company quality organization. - Establish standards/metrics to facilitate exponential growth while adhering to quality standards and regulatory guidelines. - Participate and contribute to regular functional meetings such as Supply Chain, Operational Excellence, and Sourcing, R&D. - Lead QA teams in global sites responsible for Audit management, Document control, Deviation, Change Control, CAPAs, Complaints, Adverse event reporting, final product release, and other QA related activities. - Promote customer-centric initiatives to improve customer satisfaction. - Use CAPA system to systematically improve processes and organization capabilities. - Ensure sites are prepared for Regulatory Agency Inspections and participate in the planning, review, and approval of GMP/GDP related issues of new or remodeled facility layouts. - Provide and participate in training efforts of Shalina sites on a need basis. - Provide advice and support to alliance partners, service providers, and the central distribution center to ensure compliance with Quality requirements. - Give immediate support in the form of possible corrective actions during audits and Compliance. **Qualifications Required:** - M.Pharm / B.Pharm / Master's in Science preferred. - 15+ years of leadership experience in Quality Assurance, preferably within the pharmaceutical or life sciences industry. - Strong understanding of Regulatory landscapes in semi-regulated markets and international quality standards. - Exceptional commercial acumen and strategic business insight. - Excellent consulting and communication skills (oral, written, interpersonal, presentation) with the ability to influence senior stakeholders. - Strong personal credibility and interpersonal skills with the ability to build trusted relationships with senior business leaders and teams alike. - High level of integrity and dependability with a strong sense of urgency and results-orientation. - Experience working cross-culturally and cross-functionally with diverse colleagues. As the Head of Global Quality at our company, you will play a crucial role in leading the development and execution of quality assurance strategies aligned with our long-term goals. You will partner closely with the Chief Technical Officer (CTO) and the Leadership Team to ensure robust quality management systems, regulatory compliance, and continuous improvement in operational performance. **Key Responsibilities:** - Establish best-in-class quality goals, perform quality metrics trending, apply problem solving, system improvements to meet these target levels of quality. - Lead and manage the quality teams with oversight in operations at all manufacturing facilities with a continuous improvement focus. - Build and inspire a team of QA professionals through training, mentoring, and management in the adoption of new processes and tools. - Collaborate with business units to develop quality targets for new and existing products. - Manage quality projects and activities resulting from site consolidations and acquisitions. - Collaborate with the Quality Management System group on simplification, harmonization of quality systems, and implementation across Operating Companies. - Ensure the effectiveness of the Quality System across all manufacturing sites and Contract Manufacturing site. - Implement and follow an effective Vendor/Supplier development process. - Drive recruitment activity and assure the ongoing professional development of direct reports and the overall company

As a Threat and Intelligence Analyst at Pinkerton, you will play a crucial role in developing high-quality and timely analysis on various developments, events, incidents, and trends that could impact the safety and security of our clients" corporate assets in the region. Your responsibilities will include: - Representing Pinkerton's core values of integrity, vigilance, and excellence. - Monitoring, detecting, analyzing, and advising clients on regional adverse conditions such as civil unrest, crime, environmental hazards, and terrorism. - Planning, researching, and writing regular analytical reports to deliver actionable insights and valuable results. - Actively monitoring regional security incidents to determine potential impact and staying aware of regional strategic trends. - Collecting, analyzing, and interpreting complex data using analytical techniques. - Conducting strategic analysis on large data sets, including metrics, physical security trends, incidents, and crime statistics. - Identifying gaps in current analysis products and developing new solutions to improve reporting, especially in data-driven analysis. - Supporting business continuity, crisis, and security management teams during incidents and crises. - Providing support to colleagues, including conducting peer reviews. - Performing any other duties as assigned. Qualifications required for this position include: - Bachelor's degree or higher with a minimum of two years of professional intelligence experience in the relevant sector. - Ability to produce strategic intelligence reports, threat assessments, and tailored analysis. - Effective understanding of principal geopolitical risks and their impact on the private sector. - Attention to detail and accuracy. - Capacity to carry out responsibilities with minimal supervision. - Proficiency in collecting, organizing, and analyzing complex data using analytical techniques. - Strong team player with the ability to build relationships in a complex environment and across multiple time zones. - Capability to manage multiple projects simultaneously with competing priorities and deadlines. - Proficiency in computer skills, particularly Microsoft Office. At Pinkerton, we are committed to diversity and inclusion, welcoming candidates with diverse backgrounds, experiences, and perspectives to join our team of industry subject matter experts. Please note that this role may require: - Regular computer usage. - Occasional reaching and lifting of small objects and operating office equipment. - Frequent sitting. - Travel as necessary to fulfill job responsibilities.,

As a Data Scientist at Novartis, you will have the opportunity to understand complex and critical business problems from various stakeholders and business functions. You will formulate an integrated analytical approach to mine data sources, employ statistical methods, and utilize machine learning algorithms to contribute to solving unmet medical needs, discover actionable insights, and automate processes for reducing effort and time for repeated use. Your role will involve managing the definition, implementation, and adherence to the overall data lifecycle of enterprise data, ensuring the availability of useful, clean, and accurate data throughout its useful lifecycle. Additionally, you will need to have high agility to work across various business domains. **Key Responsibilities:** - Innovate by transforming the way problems are solved using effective data management, Data Science, and Artificial Intelligence. - Articulate solutions/recommendations to business users. - Provide pathways to manage data effectively for analytical uses. - Present analytical content concisely and effectively to non-technical audiences and influence non-analytical business leaders to drive major strategic decisions based on analytical inputs. - Collaborate with internal stakeholders, external partners, institutions, and cross-functional teams to solve critical business problems and propose operational efficiencies and innovative approaches. - Evaluate the need for technology and novel scientific software, visualization tools, and new computation approaches to increase efficiency and quality of Novartis data sciences practices. - Identify research articles, reproduce/apply methodology to Novartis business problems, and contribute to cross-industry work streams in external relevant working groups. - Ensure exemplary communication with all stakeholders, including senior business leaders. - Contribute to the development of Novartis data management and data science capabilities. **Qualifications Required:** - Work Experience: 10+ years of relevant experience in Data Science. - Skills: Apache Spark, Artificial Intelligence (AI), Big Data, Data Governance, Data Literacy, Data Management, Data Quality, Data Science, Data Strategy, Data Visualization, Machine Learning (ML), Master Data Management, Python (Programming Language), R (Programming Language), Statistical Analysis. If managing a team, you will be expected to empower the team, provide guidance and coaching with limited guidance from more senior managers. Additionally, you will be responsible for the reporting of technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt. **Why Novartis:** Novartis is committed to reimagine medicine to improve and extend people's lives, striving to become the most valued and trusted medicines company in the world. By joining Novartis, you will be part of a mission-driven organization where associates are the driving force behind reaching ambitious goals. For more information on benefits and rewards at Novartis, please refer to the Novartis Life Handbook: [Novartis Life Handbook](https://www.novartis.com/careers/benefits-rewards) **Diversity and Inclusion:** Novartis is dedicated to building an outstanding, inclusive work environment with diverse teams that are representative of the patients and communities they serve. **Accessibility and Accommodation:** Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If you require accommodation during the recruitment process, please contact [email protected] with details of your request and the job requisition number. Join the Novartis Network to stay connected and learn about suitable career opportunities: [Novartis Network](https://talentnetwork.novartis.com/network),

Role Overview: As a Complaint Management Specialist, you will be responsible for overseeing complaint management and adverse event reporting. Your core activities will include initial review and categorization of complaints, determining reportability, escalating customer issues when necessary, preparing and submitting regulatory reports, coordinating with safety teams, collecting supplementary case data, updating reports, and ensuring accurate processing of all complaint files within reporting timelines. Key Responsibilities: - Prepare and send clear, compliant written responses to customer complaints related to medical devices, ensuring complete case assessment. - Address customer concerns promptly and escalate complex cases to the Specialist or Team Lead for guidance. - Deliver precise and professional information to customers through verbal and written communication. - Manage the entire complaint lifecycle from event recording to case closure or reopening as needed. - Coordinate with Subject Matter Experts and Specialists/Team Leads for effective resolution of cases. - Stay updated with organizational policies, especially those related to information security and data privacy. - Safeguard the confidentiality and integrity of company and customer information at all times. Qualifications Required: - Exceptional writing ability for composing clear complaint narratives and customer letters. - Familiarity with medical terminology and understanding of medical or pharmaceutical products in clinical settings. - Strong communication skills to engage effectively with biomedical engineers and healthcare professionals. - Analytical and critical thinking capability to identify necessary questions, gather relevant data, and interpret complaint information accurately. - Proficiency in drafting complaint summaries and customer communications. - Proficient in computer usage and documentation systems with high typing accuracy. - Excellent listening skills and a professional telephone manner. Additional Details: No additional details are present in the job description.,

**Job Description** As a **Financial Analyst**, your role involves providing expert advice on Business Planning & Analysis (BPA to superiors and offering insightful analysis and decision support to the management team. Your responsibilities include: - Supporting your direct manager in operationalizing the BPA strategic goals within a specific area of the business. Collaborate with managers on financial activities, decision-making, and various projects. - Conducting analysis and reporting with a focus on accuracy, compliance, and timely delivery of data. - Monitoring and measuring ongoing business performance, providing early warnings for resource redirection as needed. - Ensuring data integrity from commercial teams, offering value-added recommendations for forecast accuracy improvement. - Enhancing and streamlining management reporting processes and implementing lean processes. - Coordinating with other business areas (FRA, Marketing, Sales, Supply Chain, etc.) for timely and accurate information exchange. - Enhancing business case proposals, profitability tracking, and participating in budgeting, rolling forecast, and Strategic Planning processes. - Reporting technical complaints, adverse events, and other scenarios related to Sandoz products promptly. - Distributing marketing samples as required. **Key Performance Indicators:** - Internal customer satisfaction with the quality, appropriateness, and timeliness of financial analyses provided. - Reliability and accuracy of all figures delivered. **Minimum Requirements:** **Work Experience:** - Financial Management experience. - Operations Management and Execution experience. **Skills:** - Ability to Influence Key Stakeholders. - AI-Driven mindset. - Compliance and Controls proficiency. - Critical Thinking ability. - Data Cleansing/Normalization skills. - Data Visualization expertise. - Employee Engagement skills. - Financial and Management acumen. **Languages:** - English. (Note: No additional details about the company were mentioned in the provided job description.),

You would be working as a Pharmacovigilance Scientist at CONTINUUM in Chandigarh. Your role would involve managing activities related to adverse events (AEs) and serious adverse events (SAEs) for human and veterinary products. You will be responsible for processing, follow-up, analysis, and regulatory reporting of AEs and SAEs according to regulatory requirements. Additionally, you will prepare aggregate reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), and more. You will also perform signal detection-related analyses and reports. Key Responsibilities: - Manage activities related to processing, follow-up, analysis, and regulatory reporting of adverse events and serious adverse events - Prepare aggregate reports such as PBRERs, PSURs, ACOs, Addendum PSURs, PSUR Line Listings, and PADERs - Perform signal detection-related analyses and reports including cumulative analyses and issue event analyses Qualifications Required: - Masters degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, or Biophysics) - Degree in Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) or Post-Graduation in Veterinary Sciences (M.V.Sc.) - Experience in the Pharmacovigilance industry would be an advantage - Good knowledge of medical terminology and fluency in written and spoken English - Computer proficiency and ability to work with web-based applications - Familiarity with Windows 10/Window 7 professional operating system and MS Office suite (Word/Excel/Power Point) - Capability to make concise, accurate, and relevant synopses of medical text and data - Ability to write unambiguous medical text and evaluate data independently - Strong written and oral communication skills,

As a Team Lead/Manager/Senior Medical Advisor/Reviewer proficient in all aspects of clinical and post-marketing drug safety, your role encompasses various responsibilities across different phases: Key Responsibilities: - Lead as a medical monitor/Medical expert, with essential Medical Monitoring experience, effective communication with clients, and attending investigator meetings as required. - Review and provide feedback on study protocols, deliver therapeutic area training for the case processing team, and draft medical monitoring plans (MMP) ensuring compliance. - Review adverse events reported by study sites, assess severity, determine appropriate actions, make assessments on SUSAR reportability, and interpret clinical data ensuring protocol compliance. - Develop and update training materials in line with GCP and GVP requirements for medical review of all cases. - Lead the medical reviewers in post-marketing pharmacovigilance, conduct medical review of ICSRs, support in causality assessment, benefit-risk evaluation of medicinal products, mentor junior medical reviewers, and ensure competency. - Provide feedback, ongoing workshops, participate in audits and inspections, understand client needs, conventions, and ensure expectations are met. - Train and mentor other team members. Qualifications Required: - Education: MBBS or MD (Doctor of Medicine). - Experience: Minimum 10 years working for service providers or pharmaceutical companies, with at least 5-7 years of experience as a Medical Monitor or in the clinical phase. - Technical Skills: Proficiency in Microsoft package, strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety, knowledge of pharmacovigilance principles, adverse event reporting, causality assessment, working knowledge of EDC systems, good medical knowledge, and pharmacology understanding. You are expected to possess the required education, experience, and technical skills to effectively lead the medical review teams, communicate with clients, and ensure compliance with regulatory requirements in clinical and post-marketing drug safety.,

Role Overview: You will be responsible for overseeing complaint management and adverse event reporting. Your core activities will include initial review and categorization of complaints, determining reportability, escalating customer issues when necessary, preparing and submitting regulatory reports, coordinating with safety teams, collecting supplementary case data, updating reports, and ensuring all complaint files are processed accurately and within reporting timelines. Key Responsibilities: - Prepare and send clear, compliant written responses to customer complaints regarding medical devices, while gathering any missing details needed for complete case assessment. - Address customer concerns promptly and escalate complex or high-impact cases to the Specialist or Team Lead for guidance. - Deliver precise and professional information to customers through verbal and written communication. - Manage the entire complaint lifecycle from event recording and customer follow-up to case closure or reopening when necessary. - Coordinate with Subject Matter Experts (SMEs) and Specialists/Team Leads to ensure effective case resolution. - Stay current with and adhere to all organizational policies, including those related to information security and data privacy. - Safeguard the confidentiality and integrity of company and customer information at all times. Qualification Required: - Exceptional writing ability to compose clear complaint narratives, customer letters, and other documentation. - Familiarity with medical terminology and understanding of how medical or pharmaceutical products are used in clinical settings. - Strong communication skills to engage effectively with biomedical engineers and healthcare professionals for case-related details. - Analytical and critical thinking capability to identify necessary questions, gather relevant data, and interpret complaint and event information accurately. - Competency in drafting complaint summaries and customer communications. - Proficiency in computer usage and documentation systems, with strong typing accuracy. - Excellent listening skills and a professional telephone manner. Additional Details: No additional details provided in the job description.,

As a Clinical Research Associate (CRA), you will play a key role in conducting Phase I-IV clinical BA/BE studies. Your primary responsibilities will involve monitoring and managing activities at clinical sites to ensure that project timelines and deliverables are achieved. Building strong relationships with clinical sites and investigators will be essential, along with assessing protocol and regulatory compliance based on local and federal requirements, ICH GCP guidelines, and PSI SOPs. Your focus will be on safeguarding subjects" rights, safety, and well-being, as well as maintaining data quality. - Prepare, conduct, and report on various activities such as site selection, initiation, routine monitoring, and close-out visits - Monitor patient enrollment to meet recruitment targets and project timelines at both site and country levels - Verify source data, resolve data queries, and conduct ongoing reviews to ensure data quality and compliance with Risk Based Monitoring practices - Report and follow-up on Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations in a timely manner - Serve as the main communication channel between the Sponsor and the site, acting as a point of contact for in-house support services and vendors - Supervise the handling, accountability, and reconciliation of Investigational Product(s) and study supplies - Review essential documents at the site level and ensure the reconciliation of study OSF/TMF at the site and/or country level,

As a Medical Device CRA II, your role will involve site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures. You will be responsible for implementing project plans, leading projects of limited scope, and assuming line management responsibilities as assigned. Additionally, you may act as a Local Project Coordinator or Lead CRA when required. Your key responsibilities will include: - Conducting routine monitoring and closeout of clinical sites - Maintaining study files and liaising with vendors - Ensuring study staff have the necessary materials for patient enrollment - Verifying adherence to informed consent procedures and protocol requirements - Reviewing data for accuracy and completeness - Managing travel expenses efficiently - Preparing trip reports and assisting in project management - Participating in protocol development and writing clinical trial reports - Serving as a contact for clinical trial supplies and other vendors - Recruiting potential investigators and negotiating study budgets - Tracking and following up on Serious Adverse Event (SAE) reporting - Performing CRF review and query resolution - Mentoring and training new employees - Coordinating clinical projects and acting as a local client contact - Performing other duties as assigned by management Qualifications required for this role: - University or college degree in life science or related field - Minimum of 3 years relevant clinical research experience - Thorough knowledge of regulatory requirements and drug development process - Fluent in local office language and English - Clinical monitoring and site management experience - Advanced verbal and written communication skills - Ability to work with minimal supervision - Good computer skills and ability to train and supervise junior staff Preferred qualifications: - Additional experience in medical, clinical, pharmaceutical, or related field - Local project coordination or project management experience In terms of physical demands and work environment, this role will require 60-80% overnight travel. You should be comfortable sitting for extended periods, operating a vehicle, and lifting objects up to 15-20 lbs. Work will be primarily in an office environment with occasional travel to client sites, both domestic and international. If you are a proactive individual with strong organizational skills and a passion for clinical research, this role as a Medical Device CRA II could be a great fit for you. As a Medical Device CRA II, your role will involve site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures. You will be responsible for implementing project plans, leading projects of limited scope, and assuming line management responsibilities as assigned. Additionally, you may act as a Local Project Coordinator or Lead CRA when required. Your key responsibilities will include: - Conducting routine monitoring and closeout of clinical sites - Maintaining study files and liaising with vendors - Ensuring study staff have the necessary materials for patient enrollment - Verifying adherence to informed consent procedures and protocol requirements - Reviewing data for accuracy and completeness - Managing travel expenses efficiently - Preparing trip reports and assisting in project management - Participating in protocol development and writing clinical trial reports - Serving as a contact for clinical trial supplies and other vendors - Recruiting potential investigators and negotiating study budgets - Tracking and following up on Serious Adverse Event (SAE) reporting - Performing CRF review and query resolution - Mentoring and training new employees - Coordinating clinical projects and acting as a local client contact - Performing other duties as assigned by management Qualifications required for this role: - University or college degree in life science or related field - Minimum of 3 years relevant clinical research experience - Thorough knowledge of regulatory requirements and drug development process - Fluent in local office language and English - Clinical monitoring and site management experience - Advanced verbal and written communication skills - Ability to work with minimal supervision - Good computer skills and ability to train and supervise junior staff Preferred qualifications: - Additional experience in medical, clinical, pharmaceutical, or related field - Local project coordination or project management experience In terms of physical demands and work environment, this role will require 60-80% overnight travel. You should be comfortable sitting for extended periods, operating a vehicle, and lifting objects up to 15-20 lbs. Work will be primarily in an office environment with occasional travel to client sites, both domestic and international. If you are a proactive individual with strong organizational skills and a passion for clinical research, thi

Role Overview: You will be responsible for managing a team of regulatory specialists and ensuring timely regulatory submissions to support study start up. As a Manager at Velocity Clinical Research, you will proactively address challenges, drive efficiency, and provide guidance on regulatory compliance. Key Responsibilities: - Manage a team of regulatory specialists to ensure timely and efficient regulatory submissions. - Prepare study-specific documents such as protocols, informed consent forms, and HIPAA authorizations for review by the IRB. - Submit and manage amendments, adverse event reports, and other IRB-required submissions. - Provide guidance on conflict of interest paperwork and maintenance of study binders. - Identify gaps in study start-up and address potential vulnerabilities. - Develop regular reporting for executive management to demonstrate study start-up progress. - Coordinate meetings with auditors and inspectors to review regulatory files. - Stay updated on evolving regulatory trends and ensure compliance with changes in regulations. - Maintain binder accuracy, completeness, and inspection readiness. - Submit generic site material to the Velocity IRB. - Perform other duties as assigned. Qualifications Required: - Proficiency in using computers, Microsoft Office software, fax, copier, and multi-line telephone. - Strong organizational, interpersonal, and communication skills. - Ability to work in a fast-paced environment and as a team player. - Excellent written and verbal English language skills. - Demonstrated ability to multitask, mentor, and train others. - Detail-oriented with strong problem-solving and decision-making skills. - Understanding of ICH, GCP, and FDA regulatory requirements. - High School Graduate and/or technical degree required; Bachelor's degree or Associate's degree preferred. - 4-6 years of clinical research regulatory experience preferred; 2-3 years of supervisory experience preferred. Note: The Job Description provided is a general outline of the position's function and is subject to change as per Company, department, and circumstance requirements. All employees are expected to perform their duties within their capacity and as requested by management.,

Role Overview: As a Sales Representative at Novartis, you will play a crucial role in driving customer interactions and sales performance. Being the primary point of contact for customers, you will be responsible for building strong relationships to provide value for customers and patients while ensuring sales growth in a compliant and ethical manner. Key Responsibilities: - Develop business plans and execute activities such as customer events, sales & marketing campaigns, and presentations to achieve set objectives. - Be accountable for meeting sales, productivity, and performance targets within specified budgets and timelines. Provide support to key accounts/hospital networks and ensure market access and referral network support. - Possess a deep understanding of specialist areas and priority products. Stay updated on product knowledge, strategy, positioning, key messages, programs, company developments, customers, and competitors. - Achieve contact, coverage, and frequency targets through various communication channels. Ensure customer satisfaction, maintain excellent customer relationships, complete reports accurately and in a timely manner, and handle inquiries and complaints professionally. - Collaborate effectively with the Sales and Marketing team to achieve team and company objectives. Provide input on the optimal use of promotional funds and contribute to territory sales forecasting. - Adhere to adverse events guidelines and the Code of Conduct Guidelines set by Novartis. Demonstrate behavior in line with Novartis" code of practices. - If in a managerial position, take responsibility for sales planning, target setting, reporting, and team/account knowledge. Report technical complaints, adverse events, and special case scenarios related to Novartis products promptly. Distribute marketing samples as required. - Meet sales revenue and market share targets as per the plan. Manage the allocated budget for customer activities. Focus on customer satisfaction and building strong customer relationships. Engage in Sales Planning and Reporting for Key Accounts. Qualifications Required: - Minimum of 2 years of sales experience in Healthcare/Pharma or related businesses. Having an established network to target Customer Groups is desirable. - Territory knowledge is essential for this role. - A science educational background is mandatory, with a degree in B.Sc or B.Pharma. - Strong communication skills are necessary. Additional Details: Novartis is dedicated to reimagining medicine to enhance and prolong people's lives, aiming to become the most valued and trusted pharmaceutical company globally. The company values its associates who drive its ambitions every day. By joining Novartis, you become part of a mission to make a difference in the world of healthcare. If you have a passion for helping people and are interested in being part of a community that collaborates, supports, and inspires each other to achieve breakthroughs in patient care, Novartis might be the perfect place for you to create a brighter future together. To stay connected with Novartis and explore more career opportunities, you can join the Novartis Network. For detailed information on benefits and rewards offered by Novartis, you can refer to the Novartis Life Handbook.,

As a Pharmacovigilance Project Lead at ICON, you will play a crucial role in overseeing safety monitoring and reporting for clinical trials and post-marketing activities. Your responsibilities will include: - Leading and managing pharmacovigilance projects, which involves overseeing safety data collection, evaluation, and reporting processes. - Developing and implementing strategies to ensure effective management of adverse event reports and compliance with global regulatory standards. - Coordinating with cross-functional teams such as clinical operations, regulatory affairs, and data management to support project objectives and resolve safety-related issues. - Ensuring timely preparation and submission of safety reports, including periodic safety updates and risk assessments, to regulatory authorities and sponsors. - Providing leadership and guidance to pharmacovigilance teams, including training and mentoring staff to enhance project success and compliance. Qualifications required for this role include: - A Bachelor's degree in life sciences, pharmacy, or a related field; an advanced degree or certification in pharmacovigilance is a plus. - Proven experience in pharmacovigilance or drug safety with a strong understanding of safety reporting and regulatory requirements. - Strong leadership and project management skills, with experience overseeing complex pharmacovigilance projects and managing cross-functional teams. - Excellent analytical and problem-solving abilities, with a track record of driving improvements in safety monitoring processes. - Effective communication and interpersonal skills, with the ability to collaborate with diverse stakeholders and manage multiple priorities in a fast-paced environment. ICON offers a competitive salary along with a range of additional benefits designed to promote well-being and work-life balance opportunities for you and your family. Some of the benefits include various annual leave entitlements, health insurance offerings, retirement planning options, life assurance, and flexible country-specific optional benefits such as childcare vouchers, discounted gym memberships, and health assessments. ICON values diversity and high performance, and encourages individuals to apply for roles even if they do not meet all requirements. Your unique skills and experience could be a perfect match for the organization.,

Role Overview: As a Local Case Intake Advisor (Chinese language) at Global Business Services, you will be responsible for managing the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. Your role will involve supporting specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements, acting as the primary liaison between Marketing Companies and GBS-PS. Your fluency in English will be crucial as you work under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and maintain compliance with standards. Key Responsibilities: - Support the provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs). - Review, assess, and process safety data from various sources, distributing reports to internal and external third parties. - Identify Product Quality Complaint (PQC) and Product Security complaints, collecting necessary information for AE complaint reporting. - Provide prompt support for regulatory authority queries related to the Patient Safety function. - Implement Corrective and Preventative Actions in the event of local non-compliance. - Ensure reconciliations for the accuracy of pharmacovigilance data transferred and received. - Periodically screen regulatory authority databases for adverse events. - Perform literature search and related activities for MC product portfolio if required. - Undertake manual follow-up where required, disseminating clear and accurate information based on approved call scripts. - Maintain filing and archiving practices of patient safety documents. - Actively contribute to maintaining Good Pharmacovigilance Practice and being audit and inspection ready. - Support external service providers to meet company and local regulatory PV requirements. - Assist the local PS team in audits or regulatory authority inspections. - Complete all required patient safety trainings and obtain access to relevant systems. - Maintain current knowledge of relevant country regulatory authority regulations, global and local procedural documents, marketed status of products, and conditions relating to product safety. Qualifications Required: - Degree Qualified in Pharmacy/Medical/Science - Language skill in Chinese - Pharmacovigilance knowledge excellence - Good Pharmacovigilance Practice - Knowledge of health authority regulations - Cross-functional collaborative approach - Effective and lateral thinking - Problem-solving skills - Vendor management experience - Excellent attention to detail - Excellent written and verbal communication skills Additional Company Details (if present in JD): At AstraZeneca, the work directly impacts patients by transforming the ability to develop life-changing medicines. The company empowers the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Joining AstraZeneca provides the opportunity to innovate, take ownership, and explore new solutions in a dynamic environment that encourages lifelong learning. The company values in-person collaboration to unleash bold thinking and inspire life-changing medicines, balancing office expectations with individual flexibility. If you are ready to make a difference and contribute to the development of life-changing medicines, apply now to join the AstraZeneca team!,

  Collect, evaluate, and process adverse event (AE) and serious adverse event (SAE) reports from various sources (clinical trials, literature, healthcare professionals, patients). Perform case processing including data entry, coding (using MedDRA/WHO-DRL), and narrative writing in the safety database. Ensure compliance with regulatory timelines (e.g., 15-day or 7-day expedited reporting). Conduct quality checks on case reports to ensure accuracy and completeness. Assist in preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). Monitor literature and scientific publications for potential safety signals. Support signal detection and analysis activities. Maintain up-to-date knowledge of pharmacovigilance regulations and company SOPs. Collaborate with cross-functional teams including clinical research, regulatory affairs, and medical writing.