Director/Senior Director, Safety-PV Operations Lead

Added
12 hours ago
Type
Full time
Salary
Salary not provided

Related skills

vendor management pharmacovigilance argus 21 cfr part 11 safety operations

πŸ“‹ 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
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