Amgen
#WeareBiotech
Global Safety Director – Obesity
Location
United States
Posted
41 days ago
Salary
$190.0K - $246.2K / year
4 yrs expEnglish
Job Description
• Serve as the safety expert of the assigned product(s) within the Obesity portfolio
• Establish the strategy, direction, and priorities of pharmacovigilance activities
• Be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products
• Lead the Safety Analysis Team (SAT), Global Safety Team (GST) and be a core member of the Executive Safety Committee (ESC)
• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Author/review and strategize safety sections of new drug applications and associated documents and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
Job Requirements
- Doctorate degree and 4 years Safety experience OR Master’s degree and 7 years Safety experience OR Bachelor’s degree and 9 years Safety experience
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Expertise in Obesity, Metabolic/CV therapeutic area, or clinical training.
- Experience with marketed product safety; risk management
- Experience with phase 1-3 clinical trials safety assessments and analyses
- Drug Submission experience (preferably multiple new drug submission experience) and regulatory interactions
- Leadership experience of the safety profile of products assigned with cross-functional team members.
Benefits
- 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
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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