Amgen seeks a Global Safety Officer (GSO), Global Safety Medical Director - Obesity to serve as the ultimate safety expert within the Global Patient Safety organization. You will establish strategy and lead pharmacovigilance activities for assigned products, accountable for the overall safety profile and key decisions.
What You'll Do
- Validate safety signals and lead safety signal assessments
- Develop and maintain Core Safety Information including core data sheets and informed consent forms
- Prepare and review core and regional risk management plans, including additional risk minimization measures
- Prepare and review safety sections of periodic aggregate reports
- Provide safety input to protocols, statistical analysis plans, and clinical study reports
- Prepare and review safety sections of new drug applications and other regulatory filings
- Serve as the safety expert on the Evidence Generation Team for assigned products
- Maintain inspection readiness
- Travel domestically and internationally approximately 10% of the time
What We're Looking For
- MD or DO degree from an accredited medical school
- Completion of an accredited medical or surgical residency OR clinical experience in an accredited academic or private practice setting
Nice to Have
- Industry pharmacovigilance (PV) experience
- Product safety experience in the bio/pharmaceutical industry or a regulatory agency
- Previous management and/or mentoring experience
- Board certification or equivalent training
- Expertise in the Obesity/Cardiovascular therapeutic area
- Leadership experience managing a product's safety profile with cross-functional teams
Team & Environment
You will participate as a member of the Evidence Generation Team and other relevant cross-functional teams. You may be assigned as a delegate for the Therapeutic Area Head (TAH) and have management responsibilities for Global Safety Physicians.
Benefits & Compensation
- Compensation range: $243,245 to $319,267
- 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
Work Mode
This is a remote position based in the United States.
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.
