Director/Senior Director, Safety-PV Operations Lead

📋 Description

• Lead global safety and pharmacovigilance operations strategy
• Oversee safety documents with external partners (JOOs, Safety Management Plans, SAEs)
• Coordinate core safety documents with Regulatory Affairs (DSURs, RSI, CCSI, RMP/REMS)
• Ensure high-quality safety outputs with Biostatistics, QA, medical writing, vendors
• Support safety surveillance, signal management, and risk assessment
• Manage safety vendors/CROs, budgets, deliverables, and KPIs

🎯 Requirements

• Advanced life-science degree (PhD/PharmD/MSc or equivalent)
• 5+ years in pharmacovigilance or safety operations leadership
• Experience across biotech and large pharma; late-stage development experience
• Deep knowledge of global PV requirements (GVP, 21 CFR Part 11)
• Strong interaction with regulatory authorities and safety systems (Argus, Veeva, MedDRA)
• Proven CRO/vendor management and cross-functional collaboration

🎁 Benefits

• Full-time, remote position with global teams
• Influence over safety processes and governance
• Flexible hours to support multiple time zones
• Occasional travel for meetings across regions
• Inclusive, collaborative environment focused on patient impact