Director/Senior Director, Safety-PV Operations Lead

Added
35 minutes ago
Type
Full time
Salary
Salary not provided

Related skills

vendor management pharmacovigilance 21 cfr part 11 safety operations gvp

πŸ“‹ 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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