Director/Senior Director, Safety-PV Operations Lead

📋 Description

• Lead global safety and pharmacovigilance operations strategy.
• Oversee safety documents and partner agreements (GxP docs, SAD, SI, DSURs, RMP/REMS).
• Coordinate core safety materials with Regulatory Affairs.
• Ensure high-quality safety outputs with cross-functional teams.
• Support signal management, risk assessment and periodic safety reporting.
• Manage safety vendors, CROs, budgets, and performance.

🎯 Requirements

• Advanced life-science degree (PhD, PharmD, MSc or equivalent).
• 5+ years in pharmacovigilance/safety ops leadership across biotech/pharma.
• Experience with late-stage development and compassionate-use programs.
• Knowledge of global PV requirements, GVP, 21 CFR Part 11.
• Experience with safety systems/tools (Argus, Veeva, MedDRA).
• Strong communication; able to work across cross-functional teams.

🎁 Benefits

• Full-time remote position with international collaboration.
• Opportunity to influence global safety & PV operations.
• Flexible schedule across time zones; occasional travel.