Sr Medical Safety Advisor
Pharmacovigilance Safety Expert Provide PV and risk management expertise to internal and external customers Safety expert for product Maintain knowledge of product, product environment, and recent literature Maintain PV expertise, and understanding of international safety regulations and guidelines Lead cross functional Safety Management Teams (SMTs) and some Global Pharmacovigilance internal team(s) Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations Provide strategic and proactive safety input into development plans Support due diligence activities and pharmacovigilance agreements Responsible for signal detection and analysis Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group Identify and implement proactive safety analysis strategies to further define the safety profile for both marketed products and products in development Lead aggregate safety data review activities and coordinate safety surveillance activities Participate in safety governance process, including presentation of safety analyses