Director/Senior Director, Safety-PV Operations Lead

📋 Description

• Provide strategic direction for global safety and pharmacovigilance operations.
• Develop and oversee safety documents and partner agreements (JOGs, Safety Plans, DSAs).
• Coordinate core safety docs (DSURs, Reference Safety Info, RMP/REMS materials) with Regulatory
• Coordinate safety outputs with Biostatistics, QA, medical writing, vendors.
• Support ongoing safety surveillance, including signal management and risk assessment.
• Act as primary contact for safety vendors and CROs; manage budgets and deliverables.

🎯 Requirements

• Advanced degree such as PhD, PharmD, MSc, or equivalent in life-science/medical field.
• 5+ years in pharmacovigilance/safety operations leadership across biotech and pharma.
• Experience supporting late-stage development, commercialization, and expanded-access programs.
• In-depth knowledge of global PV/safety requirements (GVP, 21 CFR Part 11).
• Strong understanding of pre/post-marketing safety and regulatory expectations.
• Experience creating/maintaining CCSI and RMP/REMS docs.

🎁 Benefits

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