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 ResponsibilitiesServe 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.QualificationsMD 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.Preferred QualificationsGlobal 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. #J-18808-Ljbffr Position SummaryThe Director, Medical Safety Physician Product Lead provides medical leadership for assigned products within a global pharmacovigilance organization.