arisg-jobs-in-meerut, Meerut

7 Arisg Jobs nearby Meerut

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posted 3 weeks ago
experience2 to 6 Yrs
location
All India
skills
  • Pharmacovigilance
  • Drug Safety
  • Regulatory Reporting
  • ArisG
  • Analytical Skills
  • Written Communication
  • Verbal Communication
  • Team Collaboration
  • PV Systems
  • Oracle Argus
  • Organizational Skills
  • ProblemSolving
Job Description
As a PV Solutions Analyst for RFX & Proposals at Qinecsa, you will play a crucial role in shaping and supporting tailored pharmacovigilance operating models in response to RFXs, proposals, and client solutioning needs. Your expertise as a Subject Matter Expert (SME) for PV services will be vital in ensuring that proposed solutions are compliant, scalable, cost-effective, and aligned with global regulatory expectations. **Key Responsibilities:** - Design and support end-to-end pharmacovigilance operating models in response to RFXs and client requirements, ensuring alignment with regional and global regulatory standards. - Act as a core PV SME in authoring, reviewing, and refining RFX responses and proposals, collaborating closely with cross-functional teams (operations, regulatory, technology, and commercial). - Ensure proposed PV solutions prioritize scalability, performance, data security, and compliance with industry best practices. - Develop effort and cost estimation models based on PV activity scope to support pricing and commercial strategies. - Participate in internal proposal reviews, identifying areas for enhancement and innovation in solution offerings. - Contribute to competitive intelligence efforts by gathering insights on industry trends, pricing models, and client expectations to inform strategic positioning. **Qualifications:** - Education: Bachelor's degree or higher (preferably in Life Sciences, Pharmacy, Medicine, or a related discipline). - Experience: Minimum 2 years of relevant experience in pharmacovigilance, drug safety, or related domains, with exposure to RFX or client solutioning processes. **Required Skills & Attributes:** - Solid understanding of pharmacovigilance processes including case processing, safety database management, and regulatory reporting. - Working knowledge of PV systems such as Oracle Argus, ArisG, or other safety databases/platforms. - Strong analytical skills with the ability to translate operational needs into strategic solutions. - Excellent written and verbal communication skills; adept at contributing to formal RFX documentation and client-facing proposals. - Highly organized, detail-oriented, and capable of managing multiple priorities under tight timelines. - Team-oriented, collaborative, and able to work effectively across global and cross-functional teams. - Self-motivated with a proactive and positive approach to problem-solving and innovation. At Qinecsa, you will enjoy competitive salary packages, the opportunity to collaborate with a dynamic and innovative team, work with world-class clients, professional development, growth opportunities, and a collaborative and inclusive work environment. If you are ready to take on this exciting role, please submit your resume and cover letter to rubeena.marutla@qinecsa.com. As a PV Solutions Analyst for RFX & Proposals at Qinecsa, you will play a crucial role in shaping and supporting tailored pharmacovigilance operating models in response to RFXs, proposals, and client solutioning needs. Your expertise as a Subject Matter Expert (SME) for PV services will be vital in ensuring that proposed solutions are compliant, scalable, cost-effective, and aligned with global regulatory expectations. **Key Responsibilities:** - Design and support end-to-end pharmacovigilance operating models in response to RFXs and client requirements, ensuring alignment with regional and global regulatory standards. - Act as a core PV SME in authoring, reviewing, and refining RFX responses and proposals, collaborating closely with cross-functional teams (operations, regulatory, technology, and commercial). - Ensure proposed PV solutions prioritize scalability, performance, data security, and compliance with industry best practices. - Develop effort and cost estimation models based on PV activity scope to support pricing and commercial strategies. - Participate in internal proposal reviews, identifying areas for enhancement and innovation in solution offerings. - Contribute to competitive intelligence efforts by gathering insights on industry trends, pricing models, and client expectations to inform strategic positioning. **Qualifications:** - Education: Bachelor's degree or higher (preferably in Life Sciences, Pharmacy, Medicine, or a related discipline). - Experience: Minimum 2 years of relevant experience in pharmacovigilance, drug safety, or related domains, with exposure to RFX or client solutioning processes. **Required Skills & Attributes:** - Solid understanding of pharmacovigilance processes including case processing, safety database management, and regulatory reporting. - Working knowledge of PV systems such as Oracle Argus, ArisG, or other safety databases/platforms. - Strong analytical skills with the ability to translate operational needs into strategic solutions. - Excellent written and verbal communication skills; adept at contributing to formal RFX documentation and client-facing proposals. - Highly organized, detai
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posted 6 days ago
experience4 to 10 Yrs
location
Gujarat, Ahmedabad
skills
  • System Configuration
  • Regulatory Compliance
  • Leadership
  • Team Management
  • Client Relationship Management
  • Oracle SQL
  • PLSQL
  • Data Integration
  • Drug Safety Systems
  • Safety Report Generation
  • Adhoc
  • Aggregate Safety Reports
  • Pharmacovigilance Regulations
Job Description
Role Overview: You will be joining as a Safety System Lead or Senior Analyst in the pharmacovigilance and safety system management domain. Your primary responsibility will involve managing and optimizing Drug Safety Systems for multiple clients. As a proactive and highly organized professional, you will be expected to handle system configuration, safety report generation, and regulatory compliance efficiently. Key Responsibilities: - Lead support, configuration, and maintenance of Drug Safety Systems for multiple clients, ensuring regulatory compliance. - Mentor and lead a team of safety system analysts, providing guidance on complex system issues and optimization. - Maintain strong client relationships, ensuring their requirements are met with high-quality service and timely solutions. - Oversee the optimization of system performance, case processing workflows, and reporting functionalities. - Manage integration of Drug Safety Systems with external systems, ensuring smooth data exchange via secure gateways and E2B import/export processes. - Design, generate, and optimize Ad-hoc and Aggregate Safety Reports to ensure accuracy, compliance, and customization. - Lead troubleshooting efforts and collaborate with IT teams or vendors as needed to minimize disruptions. Qualification Required: - 4-10 years of experience in pharmacovigilance, safety system administration, or related roles with hands-on Drug Safety Systems experience. - Proven leadership experience in managing teams and client relationships while handling multiple clients. - Extensive experience in generating and customizing Ad-hoc and Aggregate Safety Reports. - Strong proficiency in Oracle SQL and PL/SQL for querying databases and generating reports. - In-depth knowledge of pharmacovigilance regulations (e.g., ICH E2E, FDA, EMA) and their impact on safety system configurations. - Experience integrating Drug Safety Systems with external systems and managing data import/export (E2B) processes. - Bachelors degree in Computer Science, Engineering, or a related field.,
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posted 3 days ago
experience10 to 14 Yrs
location
Hyderabad, Telangana
skills
  • Project management
  • Pharmacovigilance
  • Communication skills
  • Case Processing
  • PV subject matter expert
  • Problemsolving
  • PV Systems
  • Regulatory sciences
  • Clinical research solutions
  • Quality compliance
Job Description
As a PV subject matter expert at ProPharma, your role involves providing oversight and direction to enhance client service both internally and externally. You will be responsible for overseeing the development of project-specific documents, serving as a resource for the Case Processing team, and performing case follow-up activities. Additionally, you will create and review case narratives, provide client notifications, and contribute to the development of training materials. Your necessary skills and abilities for this role include strong communication skills, excellent project management abilities, high attention to detail, advanced problem-solving skills, and the capacity to work independently and collaboratively. You should also possess advanced knowledge of Pharmacovigilance and PV Systems like Oracle Argus Safety or ARISg. Furthermore, you must be self-motivated to maintain high efficiency levels and manage multiple projects and clients effectively. In terms of educational requirements, a Bachelor's degree in life sciences is required, while an advanced degree, RN, RPh, PharmD, or equivalent is preferred. The ideal candidate should have at least 10 years of related work experience in this field. ProPharma Group values diversity, equity, and inclusion in the workplace, encouraging employees to be their authentic selves and fostering an environment that supports innovation and collaboration. As an Equal Opportunity Employer, the company provides a safe space for all employees to thrive. (Note: The details regarding the company's commitment to diversity, equity, and inclusion have been included in the job description as they provide additional information about the company's values and culture.),
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posted 2 weeks ago
experience1 to 6 Yrs
location
All India, Gurugram
skills
  • RD
  • Pharmacovigilance
  • Regulatory Reporting
  • Core LS consulting
Job Description
As a Research & Development Consultant in Life Sciences at Accenture, you will be responsible for leveraging your expertise in R&D, Pharmacovigilance, and regulatory reporting to drive impactful solutions for clients. Your role will involve the following key responsibilities: - MBA from a Tier 1 institute or significant relevant industry experience - 6+ years of progressive business and/or consulting experience, with at least 1 year in the Life Sciences industry - Management consulting and general business consulting background is essential - Proficiency in utilizing assets and tools in business consulting (R&D), including issue trees, implementation frameworks, diagnosis tools, operating models, and business process mapping - Experience working with R&D functions such as Laboratory functions, clinical operations, pharmacovigilance, regulatory affairs, and quality management system - Familiarity with clinical data management platforms like Medidata/RAVE, Veeva Clinical suite, pharmacovigilance databases (ArisG & ARGUS), Regulatory Information Management Systems (Veeva RIM), and lab informatics is desirable As an industry expert, you will play a vital role in providing strategic insights and innovative solutions to our clients in the Life Sciences sector. Join us at Accenture, where you will have the opportunity to make a meaningful impact and drive positive change in the industry. As a Research & Development Consultant in Life Sciences at Accenture, you will be responsible for leveraging your expertise in R&D, Pharmacovigilance, and regulatory reporting to drive impactful solutions for clients. Your role will involve the following key responsibilities: - MBA from a Tier 1 institute or significant relevant industry experience - 6+ years of progressive business and/or consulting experience, with at least 1 year in the Life Sciences industry - Management consulting and general business consulting background is essential - Proficiency in utilizing assets and tools in business consulting (R&D), including issue trees, implementation frameworks, diagnosis tools, operating models, and business process mapping - Experience working with R&D functions such as Laboratory functions, clinical operations, pharmacovigilance, regulatory affairs, and quality management system - Familiarity with clinical data management platforms like Medidata/RAVE, Veeva Clinical suite, pharmacovigilance databases (ArisG & ARGUS), Regulatory Information Management Systems (Veeva RIM), and lab informatics is desirable As an industry expert, you will play a vital role in providing strategic insights and innovative solutions to our clients in the Life Sciences sector. Join us at Accenture, where you will have the opportunity to make a meaningful impact and drive positive change in the industry.
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posted 2 months ago
experience5 to 9 Yrs
location
All India
skills
  • System integration
  • PV systems
  • SQL programming language
  • Microsoft Office tools
Job Description
You will be assisting with the overall Safety system implementation, support, configuration, and migration activities. Your responsibility includes providing quality service to both internal and external clients in a safe and cost-effective manner while ensuring compliance with legal requirements. You will be leveraging your expertise in PV systems to combine business and technical knowledge effectively. - Conduct project-specific configurations in Safety systems. - Maintain and document system configurations based on initial requirements and any subsequent changes. - Evaluate proposed project ideas/software changes through technical impact analysis and estimated business value. - Develop and document standard and ad hoc reports from the safety systems. - Support and educate end users and sponsors as required. - Collaborate with the training team in developing safety system-specific training modules. - Initiate discussions with business stakeholders to understand requirements and ensure timely delivery. - Provide guidance on the use of standard safety systems front-end reporting and advanced conditions. - Conduct routine and ad hoc data extraction. - Participate in data migration activities and documentation. - Support change management and training of systems. - Manage tickets, resolve issues, and escalate where necessary. - Respond to mailbox queries and manage vendors. - Train team members on technical and functional aspects. - Maintain high-quality work standards, adhere to SOPs, and stay updated on PV regulations. - Update Departmental SOPs, Working Practices, and Guidelines. - Monitor system failures and resolve them promptly. - Look for ways to improve compliance, quality, and efficiency. - Perform User Acceptance Testing and complete necessary documentation. - Lead critical team projects and manage workload effectively. - Perform any other duties as assigned. - Life Science or IT/computing degree. - Relevant experience may be considered in lieu of educational requirements. - Strong team player with the ability to offer peer support. - Excellent priority-setting and multitasking skills. - Attention to detail. - Good written and verbal communication skills. - Logical and spelling skills, with an aptitude for numerical data handling and proofreading. - Proficiency in MS Office and Windows. - Experience in systems operations support role. - Experience with validated document management systems. - Clinical background in clinical systems. - Proficiency in SQL programming language. - Minimum 5 years of experience with drug safety systems like Argus/ARISg/Veeva. - Good working knowledge of Microsoft Office tools. - System integration knowledge.,
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posted 2 months ago
experience8 to 12 Yrs
location
Karnataka
skills
  • Drug Safety
  • Pharmacovigilance
  • RMP
  • BRM
  • UX
  • Development
  • ICSRs
  • Periodic reports
  • Signal Management
  • aRMM processes
  • Regulatory changes
  • PV systems like Argus
  • PV systems like ArisG
  • AgileScrum best practices
Job Description
Role Overview: As a Director of Safety Risk Management in the Healthcare/Lifesciences industry, you will work on the drug safety (pharmacovigilance) team, focusing on understanding the end-to-end PV lifecycle. Your expertise in ICSRs, Periodic reports, and Signal Management processes will be crucial. Leading and guiding RMP and aRMM processes, along with interacting with stakeholders, will be part of your responsibilities. Defining processes, utilizing swim-lane diagrams, and staying updated with regulatory changes are key aspects of the role. Key Responsibilities: - Discussing gaps and pain points with business users and translating customer needs into solutions for BRM/RMP and aRMM processes. - Collaborating with UX and Development teams to understand design and technology implications, execute the product roadmap, and develop new features. - Managing the product backlog, planning release plans, and ensuring team completion of Release/Sprint Goals. - Researching market trends, analysing user feedback, and maintaining product performance tracking. - Staying updated with Agile/Scrum best practices and industry trends. Qualifications Required: - Bachelor's degree in science or engineering. - Senior-level experience in the Pharma industry or as a Regulatory inspector. - Mastery knowledge of regulations related to the product portfolio. - Technical aptitude and excellent communication skills. - Strong time management, organizational skills, and attention to detail. - Knowledge of PV systems like Argus and ArisG will be advantageous. [Note: No additional details about the company were provided in the job description.],
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posted 2 weeks ago
experience1 to 6 Yrs
location
Karnataka
skills
  • RD
  • Pharmacovigilance
  • Regulatory Reporting
  • Core LS consulting
Job Description
As a Research & Development Consultant in the Life Sciences sector at Accenture, your role will involve utilizing your skills in R&D, Pharmacovigilance, and regulatory reporting. You will be based in locations such as Bangalore, Gurgaon, Hyderabad, or Mumbai. **Key Responsibilities:** - Possess an MBA from a Tier 1 institute or equivalent industry experience. - Have a minimum of 6 years of progressive business and/or consulting experience, with at least 1 year specifically in the Life Sciences industry. - Demonstrate expertise in management consulting and general business consulting. - Utilize assets and tools in business consulting related to R&D, including issue trees, implementation frameworks, client questionnaire analysis, operating model design, and business process mapping. - Collaborate with R&D functions such as Laboratory functions, clinical operations, pharmacovigilance, regulatory affairs, and quality management systems in a business analyst or management consultant capacity. - Familiarity with clinical data management platforms like Medidata, Veeva Clinical suite, pharmacovigilance databases (ArisG & ARGUS), Regulatory Information Management Systems (Veeva RIM), and lab informatics is preferred. Join Accenture, a leading global company, and contribute your expertise to make a difference in the Life Sciences industry.,
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