Senior Director of Drug Safety Operations

Job Summary

Providing operational leadership for pharmacovigilance activities, the full-time Senior Director of Drug Safety Operations will manage case processing, vendor governance, regulatory compliance, and quality management systems, while ensuring inspection readiness and overseeing budgets and contracts in a remote working environment.

Key Responsibilities:

• Oversee end-to-end case processing for clinical development programs, ensuring compliance and timely reporting of safety information
• Lead operational governance for DSPV vendors and service providers, defining roles, responsibilities, and deliverables
• Maintain audit and inspection readiness for DSPV activities and continuously improve the quality management system

Required Qualifications:

• Master's degree in a relevant field or equivalent combination of education and experience; nursing (RN) or pharmacy (PharmD) degree preferred
• Minimum of eight years of experience in pharmacovigilance operations within the biotechnology or pharmaceutical industry
• Hands-on experience with global safety databases, preferably Argus, and safety-data analytics
• Strong knowledge of ICH guidelines and applicable U.S. and European pharmacovigilance regulations
• Experience preparing safety-data outputs for aggregate and periodic safety reports (DSUR, 6MLLs)