Amgen Inc. is looking for a Global Safety Senior Manager, Rare Disease to join Global Patient Safety (GPS). In this vital role, you will provide scientific and compliance expertise to GPS, working with Therapeutic Safety Teams on safety assessment. You will be responsible for signal detection, data analysis, authoring safety documents, and supporting risk management and regulatory activities, all in service of patients living with serious illnesses.
What You'll Do
- Search and review adverse event data, literature, and other safety-relevant data for signal detection.
- Perform data analysis to evaluate safety signals and write up analysis results.
- Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
- Direct the planning, preparation, writing, and review of safety portions of aggregate reports.
- Prepare presentations of the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies.
- Assist GSOs in developing risk management strategy and activities, including providing content for risk management plans and regional risk management plans.
- Assist GSOs to coordinate and evaluate risk minimization activities and prepare responses to regulatory inquiries.
- Support activities related to new drug applications and other regulatory filings by assisting with strategy and providing safety content.
- Organize and direct liaison activities with affiliates and internal Amgen partners regarding products.
- Provide support for clinical trials by reviewing study-related documents and performing aggregate review of Adverse Events (AEs)/Serious Adverse Events (SAEs).
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) and maintain a state of inspection readiness.
- Serve as a representative and point of contact for Health Authority Inspections and Internal Process Audits.
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: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production.
- Knowledge of processes and regulations for pharmacovigilance and risk management.
- Clinical or medical research experience.
Team & Environment
You will work closely with Therapeutic Safety Teams and Global Patient Safety (GPS), collaborating directly with the Global Safety Officer (GSO) within Amgen's collaborative, innovative, and science-based culture.
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.
- Flexible work models, including remote and hybrid work arrangements, where possible.
Work Mode
This position offers a hybrid work model and is open to candidates in the U.S. (excluding Puerto Rico).
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.
