Global Safety Senior Manager, Rare Disease
Location: United States – Remote
Job ID: R-228638
Category: Safety
Date Posted: October 28, 2025
Work Location Type: Remote
Salary Range: USD 148,053 – 172,515
About Amgen
At Amgen, you’re part of something bigger. Since 1980, we’ve been pioneering biotechnology to combat the world’s toughest diseases. Our mission is to serve patients living with serious illnesses through innovative medicines and breakthrough science.
We focus on four key therapeutic areas:
Oncology
Inflammation
General Medicine
Rare Disease
Every year, our work helps millions of patients live longer, healthier, and happier lives. Our culture is collaborative, science-driven, and built on a shared commitment to transforming patient care—and careers.
Position Summary
The Global Safety Senior Manager, Rare Disease will work within Therapeutic Safety Teams to lead and support safety assessment and medical/scientific operations activities. The role provides scientific and compliance expertise to the Global Patient Safety (GPS) organization and contributes to the development, evaluation, and management of product safety profiles.
Key Responsibilities
Safety Data Review & Signal Detection
Search, review, and analyze adverse event data, literature, and other safety-relevant sources.
Perform data analysis and prepare reports on safety signal evaluations.
Author Safety Assessment Reports (SARs) and regulatory responses in collaboration with the Global Safety Officer (GSO).
Aggregate Report Management
Plan, prepare, and review safety sections of aggregate safety reports.
Present Global Safety Team recommendations on safety issues to cross-functional committees.
Risk Management
Support the GSO in developing and updating global and regional Risk Management Plans (RMPs).
Track and evaluate risk minimization activities and prepare responses to regulatory inquiries.
Regulatory & Clinical Support
Provide safety input for New Drug Applications (NDAs) and other filings.
Review clinical trial documentation (protocols, SAPs, CRFs, TFLs) for safety data integrity.
Conduct aggregate reviews of Adverse Events (AEs) and Serious Adverse Events (SAEs) from clinical trials.
Compliance & Inspection Readiness
Undertake delegated activities as per the Pharmacovigilance System Master File (PSMF).
Act as point of contact for Health Authority inspections and internal audits.
Ensure continuous inspection readiness and adherence to PV standards.
Cross-functional Collaboration
Coordinate with internal affiliates and partners on product safety activities.
Contribute to strategic planning for global safety initiatives.
Required Qualifications
Minimum Education & Experience:
Doctorate degree and 2+ years of experience
OR Master’s degree and 4+ years of experience
OR Bachelor’s degree and 6+ years of experience
OR Associate degree and 10+ years of experience
OR High School diploma/GED and 12+ years of experience
Preferred Qualifications
Advanced degrees such as RN, PharmD, MPH, or PA.
Extensive experience in pharmacovigilance, including:
Signal detection and evaluation
Data analysis and synthesis
Periodic safety reporting
Strong knowledge of pharmacovigilance regulations and processes.
Experience in clinical or medical research.
Compensation & Benefits
Amgen offers a comprehensive Total Rewards package, including:
Competitive base salary and discretionary annual bonus or sales incentive plan.
Stock-based long-term incentives.
Retirement and Savings Plan with generous company contributions.
Medical, dental, and vision insurance for staff and eligible dependents.
Life and disability insurance, flexible spending accounts.
Award-winning time-off programs.
Flexible work models (remote/hybrid, where possible).
Career growth and learning opportunities.
Equal Opportunity & Accessibility
Amgen is an Equal Opportunity Employer. All qualified applicants are considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
Applicants may redact personal identifiers (e.g., age, graduation year) from submissions. Reasonable accommodation is available upon request for applicants with disabilities.
How to Apply
Visit careers.amgen.com and search for Job ID: R-228638
Applications will remain open until a suitable candidate is selected.
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