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

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