Amgen Inc. is seeking a Global Safety Senior Manager to join our Global Patient Safety (GPS) team for Rare Disease. In this role, you will provide crucial scientific and compliance expertise in safety assessment activities, working closely with Therapeutic Safety Teams and Global Safety Officers to ensure patient safety.
What You'll Do
- Search and review adverse event data, literature, and other safety-relevant sources for signal detection.
- Perform data analysis to evaluate safety signals and document your analysis results.
- Author Safety Assessment Reports, regulatory responses, and other safety documents in collaboration with the Global Safety Officer.
- Direct the planning, preparation, writing, and review of safety sections within aggregate reports.
- Present the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies.
- Assist in developing risk management strategy and authoring risk management plan content.
- Coordinate and track risk minimization activities and prepare responses to related regulatory inquiries.
- Support new drug applications and regulatory filings by developing safety strategy and providing relevant content.
- Organize and direct liaison activities with Amgen affiliates and internal partners regarding product safety.
- Support clinical trials by reviewing study protocols, statistical analysis plans, and safety data collection forms, and by conducting aggregate reviews of adverse events.
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) and maintain inspection readiness.
- Serve as a point of contact for Health Authority Inspections and Internal Process Audits within your remit.
What We're Looking For
- Doctorate degree and 2 years of proven experience
- OR Master’s degree and 4 years of proven experience
- OR Bachelor’s degree and 6 years of proven experience
- OR Associate’s degree and 10 years of proven experience
- OR High school diploma / GED and 12 years of proven experience
Nice to Have
- RN, PharmD, MPH, or PA certification.
- Extensive direct experience in pharmacovigilance, including signal detection and evaluation, data analysis interpretation and synthesis, and periodic report production.
- Knowledge of pharmacovigilance and risk management processes and regulations.
- Clinical or medical research experience.
Team & Environment
You will work with Therapeutic Safety Teams and the Global Safety Officer (GSO), reporting to the Qualified Person for Pharmacovigilance (QPPV) within Amgen's collaborative, science-based culture dedicated to serving patients with serious illnesses.
Benefits & Compensation
- Compensation range: $148,053.00 USD - $172,515.00 USD.
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans.
Work Mode
This role follows a hybrid work model and is open to candidates in the U.S. (excluding Puerto Rico). Amgen offers flexible work arrangements where possible.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
