drug-accountability-jobs-in-navi-mumbai, Navi Mumbai

1 Drug Accountability Jobs nearby Navi Mumbai

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posted 2 weeks ago

Clinical Research Associate

HORIBA PVT ENTERPRISES
experience3 to 8 Yrs
location
Iran, Guinea+17

Guinea, Faridkot, Coimbatore, Zimbabwe, Iraq, Bangalore, Chennai, Raipur, Hyderabad, Kolkata, Lebanon, Faridabad, Guinea Bissau, Zambia, Mumbai City, Chandigarh, Kenya, Equatorial Guinea

skills
  • data
  • trials
  • presentation
  • computer
  • monitoring
  • literacy
  • compliance
  • clinical
  • management
  • regulatory
  • detail
  • project
  • to
  • thinking
  • skills
  • attention
  • critical
  • knowledge
Job Description
A Clinical Research Associate (CRA) is responsible foroverseeing and coordinating clinical trials to ensure they are conducted safely and effectively, monitoring data collection, ensuring regulatory compliance, and serving as a liaison between study sites, sponsors, and regulatory agencies. Key duties include setting up trials, managing trial supplies, verifying data accuracy, and preparing reports. Core responsibilities    Trial management: Plan, set up, and manage all stages of a clinical trial, from site selection to closing out the study.    Oversight and monitoring: Monitor the trial's execution to ensure it follows the protocol and complies with Good Clinical Practice (GCP) guidelines.    Data integrity: Collect, verify, and manage data to ensure its accuracy and quality.    Site communication: Act as a liaison between the clinical trial sites and the sponsor, ensuring smooth communication and resolving issues.    Regulatory compliance: Ensure all aspects of the trial adhere to relevant regulations and ethical guidelines. Typical duties    Conduct site visits to monitor the progress of the trial.    Verify source data and review trial-related documents, such as informed consent forms.    Manage trial supplies and drug accountability.    Ensure participant safety throughout the trial.    Assist in preparing post-trial reports and publications. 

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posted 2 weeks ago
experience1 to 5 Yrs
location
Pune, Maharashtra
skills
  • Medical review
  • Case processing
  • Signal analysis
  • Customer service
  • Medical safety expertise
  • Adverse event coding
  • Narrative review
  • Aggregate analysis
Job Description
Role Overview: As a Medical Safety Expert at the company, your primary responsibility will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post marketing period. This will involve undertaking the primary medical review of cases, updating and documenting case data, providing training to the case processing team, performing aggregate and signal analysis activities, and maintaining a culture of high customer service. Key Responsibilities: - Undertake primary medical review of cases, including assessing seriousness, listedness/labeling, causality, adverse event coding, and narrative review. - Update and document daily case data, case feedback in appropriate trackers/tools for tracking and workflow management. - Assume complete responsibility for all assigned deliverables ensuring expected quality, compliance, productivity SLAs, and KPIs are met. - Provide training and guidance to the case processing team on medical aspects of case processing after one year of tenure. - Perform aggregate and signal analysis activities as required to support single case processing. - Create, maintain, and ensure accountability for a culture of high customer service. Qualifications Required: - Bachelor's degree in medical science or MD or DO or equivalent degree. - Relevant and equivalent experience may be considered in lieu of educational requirements. - Language Skills: Speaking English at ILR level 3+ or higher, Writing/Reading English at ILR level 4+ or higher. Experience Required: - Working knowledge of medical sciences, diagnosis, and therapeutics including drug treatments and procedures. - Knowledge and understanding of regulatory requirements for Clinical Research. - Familiarity with ICH-GCP guidelines. Additional Company Details: The company offers a physical demands/work environment that can be office-based or home-based as requested by the line manager. For more information about Equal Employment Opportunity and Accommodations requests, you can refer to the company's EEO & Accommodations policy.,
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posted 2 months ago
experience4 to 8 Yrs
location
Pune, Maharashtra
skills
  • Signal Detection
  • Risk Management
  • Medical Writing
  • Regulatory Submissions
  • Clinical Research
  • Pharmacovigilance
  • Safety Reports Writing
  • BenefitRisk Evaluation
  • ICH GCP Guidelines
Job Description
Role Overview: You will lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Your responsibilities include end-to-end report management, planning, authoring, managing review and submission steps, applying safety domain knowledge, managing deliverables of medium to high complexity, and ensuring timely delivery of high-quality documents to internal customers and sponsors/clients. You will coordinate activities related to several types of report writing across a team of writers, perform support activities such as tracking, maintenance of metrics, quality checks, and training, and assist Medical Writers in preparing safety reports. Building excellent working relationships with all clients, both internal and external, is crucial. Key Responsibilities: - Generate line listings and summary tabulation, CFIs, CFCs - Write and review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Development Safety Update Report, and other clinical documents - Write Common Technical Document Summaries and other regulatory documents - Author/review RMPs, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, and supporting documents - Prepare medical information responses for HCPs - Act as a writing coach - Coordinate report writing activities, oversee schedules, allocate team resources, and communicate with different teams - Liaise with clients and act as a primary point of contact for report writing activities - Perform support activities such as tracking, metrics maintenance, quality checks, and training - Assist in resource estimation and RFP responses - Conduct internal and external communication and coordination for project inputs - Resolve issues affecting project deliverables - Update labels like Core Data Sheets, USPI, centralized SPCs, Med Guides - Conduct literature searches for various reports, recommend label changes, author proposed label text, and prepare supporting documents - Implement efficient processes to meet timelines and deliverables, ensure regulatory compliance, and assume accountability for deliverables - Perform any additional activities as per project requirements or manager's discretion Qualification Required: - Minimum of a first degree in life sciences or equivalent - Relevant experience may be considered in lieu of educational requirements - 5-7 years of experience in the pharmaceutical industry, or 4 years in medical writing - Experience in drug discovery and pharmacovigilance is desirable Additional Company Details (if available): - Physical Demands/Work Environment: Client office as per assignment and/or home-based office, available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location,
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posted 2 months ago

Staff Nurse ICU

SRV Hospital
experience0 to 5 Yrs
location
Maharashtra
skills
  • Communication skills
  • Adaptability
  • Ability to work in a team
  • Attention to detail
Job Description
Role Overview: As a Nurse, your primary responsibility will be to provide direct patient care by performing various nursing procedures including admission and discharge processes, maintaining personal hygiene and comfort of patients, attending to their nutritional needs, and administering medications. You will also be responsible for coordinating patient care with other team members, assisting doctors in medical procedures, and documenting all procedures accurately. Additionally, you will be involved in ward/ICU/unit management, maintaining cleanliness, supervising duties of support staff, and managing records related to patient care. Key Responsibilities: - Carry out admission and discharge procedures of patients - Make beds of serious patients and assist in bed-making for other patients - Maintain personal hygiene and comfort of patients - Attend to nutritional needs and feed helpless patients - Implement and maintain ward policies and routines - Coordinate patient care with other team members - Perform various technical tasks related to nursing care - Administer medications and assist in medical procedures - Maintain records and reports of all procedures - Manage ward/ICU/unit by ensuring cleanliness, supervising staff, and maintaining necessary equipment - Procure necessary equipment and drugs for postoperative/ICU/burns units - Operate critical care equipment and participate in appraisal schemes Qualification Required: - ANM, GNM, BSc, PBBSc - Minimum 0 to maximum 5 years of experience Key Skills: - Excellent communication skills and confidence - Ability to work effectively in a team - Attention to detail and adaptability to work under pressure Additional Details: The company emphasizes on the importance of good communication skills, accountability, staff development, continuous learning, and maintaining a respectful and supportive work environment. Nurses are encouraged to participate in annual appraisals, update their knowledge, and ensure accurate documentation as required. Regular attendance in nursing education sessions is also expected to stay updated with current concepts and patient care methods. (Note: Benefits, schedule, language preference, and work location details are provided in the original job description but omitted here for brevity.),
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posted 3 days ago
experience5 to 9 Yrs
location
Pune, Maharashtra
skills
  • Analysis
  • Data Integrity
  • Knowledge Management
  • Customer Focus
  • Customer Management
  • Communication
  • Learning Onboarding
  • Strategic Projects
  • Agile Frameworks
  • Consultancy Skills
Job Description
In this role within the Learning Services department of People & Culture (P&C), you will be responsible for partnering with the Learning Design Hub to transform project requirements into effective learning solutions. Your primary accountability will be to ensure the successful implementation of content into the Learning Management System (Cornerstone) and projects supporting learning initiatives within bp. You will report directly to the Design Integration Lead. Key Accountabilities and challenges: - Learning Onboarding - Adding new content to all bp learning systems and integrating it into global operating processes, ensuring all key teams are well-informed and prepared to operationalize the new content - Analyzing existing content to maintain the health and maturity of the learning catalogue - Ensuring data integrity across all platforms and consistent knowledge/information management to support reporting requirements - Confidential - Understanding business requirements thoroughly and acting as a trusted advisor to deliver scalable solutions that drive the desired outcomes - Providing guidance on best practices for deploying learning within bp and safeguarding the quality of the learner journey through effective solutions - Establishing and nurturing strong working relationships with other Learning Services teams to ensure a unified approach to learning and ongoing quality of service - Strategic Projects - Supporting and driving P&C Services + Solutions initiatives by collaborating with P&C communications and partnering with the Global Solutions Organization (GSO) through various project work streams and networking channels - Leading and participating in continuous improvement projects using Agile frameworks - Delivering assigned projects within specified timeframes and quality standards while communicating and addressing risks proactively Qualifications, Competencies & Attitude: - Bachelor's degree or equivalent experience - Extensive experience in learning process or learning system implementation and maintenance, with strong analytical skills and attention to detail - Proficiency in digital technologies to collaborate with tech teams for implementing high-quality digital solutions - Customer-centric approach aligning decisions with customer and business strategies - Customer management skills to engage and influence key business stakeholders, with basic consultancy abilities and a coaching mindset to build trust Please note that this role may require adherence to local policies, including pre-employment drug screening, medical assessments, and background checks. If selected, reasonable accommodations will be provided for individuals with disabilities during the application process, interviews, and job functions. This position offers relocation assistance within the country and involves a hybrid of office and remote working. Travel requirements for this role are expected to be negligible. The shift timings for this position are from 6:30 PM to 3:30 AM.,
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posted 1 day ago
experience5 to 9 Yrs
location
Pune, Maharashtra
skills
  • Finance
  • Cost Accounting
  • Business Administration
  • Industrial Engineering
  • SAP
  • Stakeholder Management
  • Microsoft Office
Job Description
As a Cost Accountant at Kimberly-Clark, you will play a vital role in leading the calculation of standard cost processes across Latin America. Your expertise and attention to detail will ensure accurate information is provided for making informed business decisions. Your responsibilities will include: - Leading the standard cost update process, ensuring accurate calculations and clear assumptions for the next quarter - Supporting standard cost calculation, release process, and monthly close activities in compliance with financial controls - Questioning inputs, tracking progress, identifying root causes of deviations, and implementing action plans to improve forecast accuracy - Analyzing and explaining changes to standard cost and operating results to aid client understanding - Collaborating with finance and supply chain teams to improve forecasting processes - Assisting in decision-making processes for capital investments, new projects costing, benchmark data, and ad hoc analyses - Reporting on cost analyses and ensuring accurate preparation of journal entries and account reconciliations Qualifications required for this role include: - 5-8 years of finance experience in supply, operations, and cost accounting - Bachelor's degree in Business Administration, Industrial Engineering, or Finance - Demonstrated critical thinking and technical skills - High level of ownership, accountability, stakeholder management, and influencing skills - Experience with Microsoft Office and SAP - Intermediate-Advance level of English proficiency About Kimberly-Clark, you will be part of a team committed to driving innovation, growth, and impact through legendary brands like Huggies, Kleenex, and Scott. With over 150 years of market leadership, Kimberly-Clark offers an open door of opportunity for talented professionals like you. If you are ready to contribute to Better Care for a Better World, click the Apply button to complete the online application process. Kimberly-Clark's recruiting team will review your application for consideration. Employment at Kimberly-Clark is subject to verification of pre-screening tests, including drug screening, background check, and DMV check. Primary Location: Pune Kharadi Hub Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time,
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posted 2 months ago
experience8 to 12 Yrs
location
Pune, Maharashtra
skills
  • Analytics
  • Business Analysis
  • Coaching
  • Communication
  • Digital Project Management
  • Facilitation
  • Information Security
  • Mentoring
  • Risk Management
  • Stakeholder Management
  • Supplier Relationship Management
  • System Design
  • Agility core practices
  • Configuration management
  • release
  • Documentation
  • knowledge sharing
  • Metrics definition
  • instrumentation
  • Service operations
  • resiliency
Job Description
Role Overview: As a Principal Delivery Manager Marketing at bp, you will lead a cross-functional squad of product and software engineering team members dedicated to delivering the future of mobility, energy, and services for customers globally through innovative business models and service platforms. You will collaborate with colleagues across various regions to differentiate customer experiences and deliver breakthrough business value. Your primary accountability will be to oversee the development and implementation of digital products, platforms, and services designed to enhance customer experience across bp. Key Responsibilities: - Oversee projects involving the development and implementation of products, platforms, and business processes to achieve desired business outcomes - Create and manage roadmaps, schedules, and budgets while acting as the main liaison between stakeholders, development teams, and business units globally dispersed - Monitor the health and key performance characteristics of products, platforms, or services to increase performance, ensure compliance, and optimize operation - Strategically manage internal teams, external suppliers, and technology partners to balance capacity and ensure efficient delivery without compromising quality - Oversee budget planning, allocation, and tracking to ensure alignment with business objectives - Champion transparency, financial performance monitoring, and resource utilization optimization across projects, platforms, or services Qualifications Required: - Significant experience working across complex, globally dispersed businesses - Computer Science degree or equivalent work experience - Successful large-scale application of Agile, Lean, and project delivery methods - Excellence in balancing strategic priorities with tactical execution, attention to detail, and outstanding communication and influence skills - Motivated by complex problem-solving challenges and passion for making things happen - Commercial mindedness to maximize business value delivered - Appreciation of multi-discipline squads and ability to leverage team members to drive optimal outcomes About Bp: bp is a global energy business committed to reimagining energy for people and the planet. By 2030, bp aims to be a different kind of energy company, helping the world reach net zero and improving lives. They are dedicated to creating a diverse and inclusive environment where everyone can thrive. Join bp and be part of the team building the future! Legal Disclaimer: Employment may be contingent upon adherence to local policy, including pre-placement drug screening, medical review, and background checks.,
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