Director/Senior Director, Safety-PV Operations Lead

📋 Description

• Provide strategic direction for global safety and pharmacovigilance operations, ensuring an
• Develop, maintain, and oversee safety operational documents and agreements with external partners
• Coordinate the development of core safety documents, including DSURs, Reference Safety Information
• Coordinate high-quality safety outputs with Biostatistics, Quality Assurance, medical writing, and
• Support ongoing safety surveillance, including signal management, risk assessment, and periodic
• Serve as the primary point of contact for safety vendors and CROs, managing work orders, budgets

🎯 Requirements

• Advanced degree such as a PhD, PharmD, MSc, or equivalent in a life-science or medical discipline.
• At least 5 years of experience in a comparable pharmacovigilance or safety operations leadership
• Demonstrated experience supporting late-stage clinical development, initial commercialization, and
• In-depth knowledge of global pharmacovigilance and safety requirements, including GVP and 21 CFR
• Strong understanding of pre- and post-marketing safety requirements and global regulatory
• Experience creating and maintaining CCSI and initial RMP/REMS documentation.

🎁 Benefits

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