Global Safety Manager
Location: United States – Remote
Job ID: R-220068
Category: Safety
Date Posted: October 15, 2025
Work Location Type: Remote
Salary Range: USD 122,105 – 145,799
About Amgen
At Amgen, we are driven by a shared purpose — to serve patients living with serious illnesses. Since 1980, we’ve pioneered advances in biotechnology, developing innovative treatments for the world’s most challenging diseases.
Our work focuses on four core therapeutic areas:
Oncology
Inflammation
General Medicine
Rare Disease
We reach millions of patients every year through science, innovation, and collaboration. Join our award-winning, patient-centered culture and help us transform lives while growing your career.
Position Overview
As a Global Safety Manager, you will join the Immuno-Oncology Pharmacovigilance (PV) team, working collaboratively with Global Safety Officers (GSOs) to support the safety strategy and deliverables for Amgen products.
This role involves signal detection, safety data analysis, and aggregate reporting, contributing to products across early development to post-marketing stages.
Key Responsibilities
Aggregate Reporting & Documentation
Plan, prepare, write, and review periodic aggregate safety reports.
Assist in safety data analysis and contribute to Safety Assessment Reports (SARs) and other regulatory documents.
Support regulatory filings, including safety sections of New Drug Applications (NDAs) and other submissions.
Safety Data Review & Signal Management
Review adverse events (AEs) and serious adverse events (SAEs) from clinical trials.
Conduct signal detection, evaluation, and management, including data analysis and literature review.
Prepare and present safety signal assessments and recommendations to decision-making teams.
Clinical Study Support
Review study protocols, statistical analysis plans (SAPs), and data collection forms for safety-related content.
Provide input on tables, figures, and listings (TFLs) for clinical safety data.
Participate in study team meetings as needed to discuss ongoing safety evaluation.
Risk Management & Governance
Contribute to Risk Management Plans (RMPs) — both core and regional versions.
Support risk minimization activities, including monitoring, evaluation, and regulatory responses.
Participate in Safety Governance meetings following Amgen processes.
Collaboration & Process Compliance
Collaborate with Amgen affiliates and internal partners to align global safety deliverables.
Maintain inspection readiness by following Amgen’s PV standards and Standard Operating Procedures (SOPs).
Perform additional PV-related duties as assigned.
Required Qualifications
Doctorate degree, OR
Master’s degree with 2 years of relevant experience, OR
Bachelor’s degree with 4 years of relevant experience
Preferred Qualifications
Background as a Healthcare Professional (e.g., PharmD, RN, MPH, or related field).
Minimum 1 year of experience in Drug Safety / Pharmacovigilance (PV).
Proficiency in:
Signal detection, evaluation, and management
Aggregate safety reporting (e.g., PBRER, DSUR, PSUR)
Literature surveillance and source document review
Argus Safety Database
Strong clinical and scientific judgment with understanding of study design and safety monitoring.
Excellent written and verbal communication skills.
Experience in clinical or medical research preferred.
Compensation & Benefits
Amgen offers a Total Rewards Plan to support both your professional growth and personal well-being.
Compensation:
Annual Salary Range: USD 122,105 – 145,799 (varies based on experience and qualifications)
Annual bonus or sales incentive program
Stock-based long-term incentives
Benefits:
Retirement & Savings Plan with company contributions
Comprehensive medical, dental, and vision coverage for employees and dependents
Life and disability insurance
Flexible Spending Accounts (FSA)
Award-winning time-off programs
Flexible work models – Remote or Hybrid (where possible)
Career development opportunities and continuous learning
Equal Opportunity & Accessibility
Amgen is an Equal Opportunity Employer committed to diversity, equity, and inclusion.
All qualified applicants will be considered without regard to:
race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
Applicants may remove or redact age-identifying information (e.g., date of birth, school dates) from application materials.
Amgen provides reasonable accommodations for applicants with disabilities during the application and employment process.
How to Apply
Visit careers.amgen.com
Search for Job ID: R-220068 and click Apply Now
📅 Application Deadline:
Open until sufficient applications are received or a suitable candidate is selected.
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