Director/Senior Director, Safety-PV Operations Lead
JobgetherRemotely
pharmacovigilancevendor managementsafety operations21 cfr part 11remsrmpgvpdsur
Job Description
📋 Description
- Lead global safety and pharmacovigilance operations strategy.
- Oversee safety documents and partner agreements (GxP docs, safety plans, safety data exchange).
- Coordinate core safety outputs with regulatory affairs and cross-functional teams.
- Ensure safety surveillance, signal management, and risk assessment activities.
- Manage safety vendors, CROs, budgets, and performance.
- Represent safety in governance forums and with development/ commercialization partners.
🎯 Requirements
- Advanced degree (PhD/PharmD/MSc or equivalent) in life sciences.
- 5+ years in pharmacovigilance or safety ops leadership in biotech/pharma.
- Experience supporting late-stage development and compassionate use programs.
- Deep knowledge of global PV requirements (GVP, 21 CFR Part 11).
- Experience with safety systems/tools (Argus, Veeva, MedDRA).
- Strong cross-functional collaboration and vendor management skills.
🎁 Benefits
- Full-time, remote position with flexible work environment.
- Work across Europe, North America, and Israel.
- Flexible schedule for multiple time zones.
- Influence global PV operations and strategy.
- Occasional travel for in-person meetings across multiple regions.
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