Global Pharmacovigilance Safety, Senior Manager- Obesity
Skills
About the role
This is a senior pharmacovigilance manager role at Amgen, based in Washington D.C., focused on safety assessment for obesity and related therapeutic products. It suits an experienced drug safety professional who can lead signal detection, risk management and regulatory safety documentation. You'll work with Therapeutic Safety Teams, author safety assessment reports, and support inspection readiness.
What you’ll do
- Direct the planning, preparation and review of aggregate safety reports
- Support clinical trial safety reviews including AEs and SAEs
- Perform signal detection, evaluation and management analysis
- Author Safety Assessment Reports and regulatory responses
- Search and review adverse event data and literature for signal detection
- Contribute to risk management plans and oversee risk minimization activities
- Support inspection readiness and act as point of contact for audits
What they’re looking for
- Doctorate plus 2 years of industry pharmacovigilance experience, or Master's plus 4 years, or Bachelor's plus 6 years, or Associate's plus 10 years, or high school diploma plus 12 years
Nice to have
- Bachelor's in life science plus Master's and 6 years of related experience
- 2 years of managerial or mentoring experience
- Clinical or medical research experience
- 6 years of experience in the biotech or pharmaceutical setting
What’s on offer
- Retirement and savings plan with company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Discretionary annual bonus program
- Stock-based long-term incentives
- Flexible work models where possible
Questions about this role
How many years of experience do I need?
Amgen accepts a Doctorate with 2 years, a Master's with 4 years, or a Bachelor's with 6 years of pharmacovigilance experience, among other combinations.
Is this role remote?
The posting does not describe remote work; it names flexible work models where possible.
Is sponsorship available?
The posting states sponsorship for this role is not guaranteed.
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