Director of Pharmacovigilance

Darum lohnt es sich

This role is responsible for benefit-risk assessment, signal detection, safety surveillance, risk management, regulatory safety strategy, and cross-functional leadership across the product lifecycle from early development through commercialization.

Key Responsibilities • Serve as the medical safety lead for assigned products and development programs. • Maintain oversight of product safety profiles and benefit-risk evaluations. • Lead signal detection, safety surveillance, and risk management activities. • Chair Safety Management Team (SMT) meetings and safety governance forums. • Author and review key safety documents including DSURs, PSURs/PBRERs, RMPs, CCDS, Investigator Brochures, clinical protocols, and study reports. • Provide strategic safety leadership for IND, NDA, BLA, and MAA submissions. • Lead safety responses to health authorities and regulatory agencies. • Partner with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and Commercial teams. • Oversee safety labeling activities and ensure consistency across global product information. • Provide medical oversight of ICSR review and aggregate safety analyses. • Support clinical trial safety monitoring, database reconciliation, and review of safety data outputs. • Act as pharmacovigilance representative on cross-functional product teams. • Support inspections, audits, and health authority interactions as a subject matter expert. • Mentor team members and contribute to process improvements across the global safety organization.

Qualifications • MD or equivalent medical degree required. • 7+ years of pharmacovigilance, drug safety, or medical safety experience within the pharmaceutical or biotechnology industry. • Strong understanding of global pharmacovigilance regulations, including FDA and EU GVP requirements. • Experience supporting clinical development programs and major regulatory submissions. • Demonstrated expertise in signal detection, benefit-risk assessment, safety surveillance, and risk management. • Experience authoring and reviewing aggregate safety reports and regulatory safety documents. • Strong leadership, communication, and stakeholder management skills. • Ability to work effectively in a global, matrixed environment.

Position Summary The Director, Medical Safety Physician Product Lead provides medical leadership for assigned products within a global pharmacovigilance organization.

Preferred Qualifications • Global product safety lead experience. • Experience supporting products across multiple stages of development and commercialization. • Background in epidemiology, biostatistics, or risk management. • Experience leading regulatory inspections and health authority interactions.