Director/Senior Director, Safety-PV Operations Lead

📋 Description

• Provide strategic direction for global safety and pharmacovigilance operations, ensuring an
• Develop, maintain, and oversee safety documents with external partners (JOGs, Safety Plans, SDEA).
• Coordinate core safety documents (DSURs, Reference Safety Information, CCSI, RMP/REMS) with
• Coordinate high-quality safety outputs with Biostatistics, QA, medical writing, and external
• Support ongoing safety surveillance, including signal management and periodic safety reporting.
• Serve as primary contact for safety vendors/CROs, managing budgets and deliverables.

🎯 Requirements

• Advanced degree such as PhD, PharmD, MSc, or equivalent in life sciences.
• At least 5 years in a comparably senior PV/safety ops leadership role across biotech and large
• Experience supporting late-stage development, initial commercialization, and
• In-depth knowledge of global PV/safety requirements, including GVP and 21 CFR Part 11.
• Strong understanding of pre- and post-marketing safety and global regulatory expectations.
• Experience creating/maintaining CCSI and initial RMP/REMS documentation.

🎁 Benefits

• Full-time, remote position with flexible working environment.
• Opportunity to work across international teams in Europe, North America, and Israel.
• Flexible schedule to support collaboration across time zones.
• Contribute to late-stage development and future commercialization programs.
• Significant ownership and strategic influence over global safety and PV operations.
• Occasional travel for in-person meetings and team collaboration.