Senior PV Scientist
This is a fully remote role for an international pharma company based in canton Zug.
You will serve as a global product lead for Pharmacovigilance activities within the Safety department, managing PV Scientists assigned to products. Your tasks and responsibilities include leading the signal management process, evaluating safety data and signals, providing safety leadership, and developing Pharmacovigilance Plans.
* Main Responsibilities:
* Leads the signal management process (signal detection, tracking, documentation, facilitating decisions regarding signals and safety risk)
* Evaluates safety data and signals as part of ongoing pharmacovigilance activities
* Provides safety leadership to cross-functional project meetings
* Develops Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans, and Risk Management Plans
* Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs
A typical day might include working on post-marketing and/or investigational products, setting response strategy, performing routine signal detection and safety surveillance activities, reviewing key safety documents, and working cross-functionally to deliver process improvement initiatives.
Your Profile:
* 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
* Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format
* Strong pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations