Director/Senior Director, Safety-PV Operations Lead

Added
7 days ago
Type
Full time
Salary
Salary not provided

Related skills

vendor management pharmacovigilance veeva argus dsur
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πŸ“‹ Description

  • Lead global pharmacovigilance safety operations strategy
  • Oversee safety docs and external partner agreements
  • Coordinate core safety documents with Regulatory Affairs
  • Ensure quality safety outputs with cross-functional teams
  • Support signal management and periodic reporting
  • Manage safety vendors, CROs, budgets, and SLAs

🎯 Requirements

  • Advanced life-sciences degree (PhD, PharmD, MSc, or equivalent)
  • 5+ years in pharmacovigilance/safety operations leadership
  • Experience with late-stage development and compassionate-use programs
  • In-depth knowledge of GVP and 21 CFR Part 11
  • Understanding global safety requirements and regulatory expectations
  • Experience with safety systems such as Argus and Veeva

🎁 Benefits

  • Full-time, remote position with flexible environment
  • Work across Europe, North America, and Israel
  • Flexible schedule for multiple time zones
  • Impact global safety and pharmacovigilance strategy
  • Occasional travel for face-to-face collaboration
  • Inclusive, patient-focused culture
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