Director/Senior Director, Safety-PV Operations Lead
JobgetherNorth AmericaFull TimeHealthcare
Remotely
pharmacovigilancevendor managementsafety operations21 cfr part 11argusgvpdsurrmp/rems
Job Description
📋 Description
- Lead global safety and pharmacovigilance operations strategy
- Develop and oversee safety documents with external partners
- Coordinate core safety materials with Regulatory Affairs
- Ensure high-quality safety outputs with cross-functional teams
- Support safety surveillance, signal management, and risk assessment
- Manage safety vendors/CROs, budgets, and performance
🎯 Requirements
- Advanced life-science or medical PhD/PharmD/MSc or equivalent
- 5+ years in pharmacovigilance/safety operations leadership
- Experience with late-stage development, commercialization, and expanded-access
- Deep knowledge of global PV requirements (GVP, 21 CFR Part 11)
- Familiarity with safety systems/tools (Argus, Veeva, MedDRA)
- Proven CRO/vendor management and cross-functional collaboration
🎁 Benefits
- Full-time, remote position with global teams
- International collaboration across Europe, NA, and Israel
- Flexible schedule for multiple time zones
- Opportunity to influence global safety programs and strategy
- Occasional travel for in-person meetings
- Inclusive work culture focused on patient impact