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Senior Pharmacovigilance Expert
vor 2 Wochen
Description of the Role:
We are looking for a highly skilled Senior PV Scientist to join our team at Randstad. The successful candidate will have a strong background in pharmacovigilance and drug development, with experience in safety signal management and aggregate safety reports.
The Senior PV Scientist will be responsible for leading the signal management process, evaluating safety data and signals, and providing strategic input to the authoring of regulatory documents.
Main Tasks:
- Lead the signal management process, including signal detection, tracking, documentation, and facilitating decisions regarding signals and safety risk
- Evaluate safety data and signals as part of ongoing pharmacovigilance activities, synthesizing data from multiple sources and authoring signal evaluation reports
- Develop Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs)
- Maintain an up-to-date understanding of relevant global safety regulations and guidelines
Requirements:
- MSc or BSc in biologic or natural science; or health care discipline advanced degree (PhD, MPH, NP, PharmD, etc.) required
- Minimum 7 years Pharmacovigilance experience, including experience in safety signal management and aggregate safety reports
- Strong pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations
