Global Pharmacovigilance (PV) Scientist, Senior Manager

Role: Global Pharmacovigilance Senior Manager overseeing safety assessment activities for Amgen's therapeutics. Main objectives include safety data review, signal detection, risk management, and regulatory support for oncology, inflammation, and rare disease products across development stages. Responsibilities encompass leading aggregate safety report preparation, safety data analysis, signal evaluation, and supporting risk minimization strategies and regulatory filings. Collaboration occurs with therapeutic safety teams, affiliates, GSO, and regulatory authorities, with a focus on inspection readiness. Requirements: Doctorate with 2+ years, Master's with 4+ years, Bachelor's with 6+ years, or equivalent industry pharmacovigilance experience; strong knowledge of safety data analysis, signal management, and literature review; clinical or medical research background preferred. High-value specifics include expertise in drug safety for biologics or small molecules in clinical development, signal detection, and regulatory compliance. The role may involve cross-functional interactions in clinical and regulatory teams, with an emphasis on safety documentation and risk management planning.