Manager Global PV Aggregate Reporting Specialist
3 weeks ago
We are seeking a highly skilled Manager Global PV Aggregate Reporting to join our team at Lifelancer. The successful candidate will be responsible for leading the development and implementation of global pharmacovigilance aggregate reporting processes and procedures.
Key Responsibilities- Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements.
- Lead and manage a team of pharmacovigilance professionals to ensure timely and accurate submission of aggregate reports.
- Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting.
- Stay up-to-date with regulatory changes and industry trends related to pharmacovigilance aggregate reporting and implement necessary changes to processes and procedures.
- Develop and maintain systems, tools, and processes for drug safety operations.
- Bachelor's degree in a health or life sciences field.
- 5 years of experience in the pharmaceutical or related industry with 2 years of experience in Pharmacovigilance.
- Proven experience working in a matrix environment and cross-functional teams.
- Comprehensive clinical/medical writing experience.
- Strong English verbal and written communication skills.
- Strong knowledge of global pharmacovigilance regulations and guidelines.
- Ability to work collaboratively with cross-functional teams.
- Strong analytical and problem-solving skills.
- Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.).
- Strong leadership and presentation skills.
- Experience in developing and implementing drug safety policies and operating procedures.
- Ability to work in a fast-paced environment and manage multiple projects simultaneously.
- SME with in-depth product knowledge of assigned products; knowledge and hands-on experience in aggregate reports writing and compliance management.
- In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies.
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Global PV Aggregate Reporting Manager
3 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeJob Title: Manager Global PV Aggregate ReportingKenvue is a leading life sciences company that is currently recruiting for a Manager Global PV Aggregate Reporting position. This role is based in Mumbai or Pune, India, and reports to the Associate Director Global PV Aggregate Reporting and Risk Management.Job Summary:The Manager Global PV Aggregate Reporting...
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Global PV Aggregate Reporting Manager
3 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeJob SummaryWe are seeking a highly skilled Global PV Aggregate Reporting Manager to join our team at Lifelancer. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the timely and accurate submission of aggregate reports to regulatory authorities. This role requires a strong understanding of global pharmacovigilance...
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Mumbai, Maharashtra, India Lifelancer Full timeAt Lifelancer, we are currently recruiting for a highly skilled Global Aggregate Reporting and Risk Management Manager to join our team. This is a fantastic opportunity for an experienced professional to take on a key role in ensuring the highest standards of safety for our products.Key Responsibilities:Ensure timely and accurate submission of aggregate...
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Senior Aggregate Reporting Manager
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