Global Pharmacovigilance Senior Scientist

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

The Global PV Senior Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise to Global Patient Safety (GPS).

* Directs the planning, preparation, writing and review of portions of aggregate reports * Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products * Supports and provides oversight to staff with regards to safety in clinical trials to review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents * Review of AEs/SAEs from clinical trials * Review standard design of tables, figures, and listings for safety data from clinical studies * Participate in development of safety-related data collection forms for clinical studies * Participate in study team meetings * Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results * Documents work in the safety information management system * Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO * Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection * Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body * Assist GSO in the development of risk management strategy and activities: Provides contents for risk management plans; Develop or update strategy and content for regional risk management plans; Assist GSOs to oversee risk minimization activities including tracking of activities; Evaluate risk minimization activity; Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO * Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities; Provide safety contents for filings * Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness * Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

* RN, PharmD or PA * Clinical/medical research experience * Processes and regulations for pharmacovigilance and risk management * Aggregate data analysis, interpretation and synthesis * Signal detection, evaluation and management * 6 years of experience in a biotech/pharmaceutical setting * Previous management and/or mentoring experience **Basic Qualifications** * Doctorate degree and 2 years of Safety experience * Master’s degree and 6 years Safety experience * Bachelor’s degree and 8 years of Safety experience * Associate’s degree and 10 years of Safety experience * High school diploma / GED and 12 years of Safety experience