Global Safety Director, Obesity – US, Remote
About The Position
In this vital role you will serve as the safety expert of the assigned product(s) within the Obesity portfolio and be pivotal in getting our drugs to market. You will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). Serve as a member of the Evidence Generation Team and other relevant cross-functional teams and will be assigned as delegated for the Therapeutic Area Head (TAH). Work in a fast-paced environment with a dynamic team of safety physicians and scientists dedicated to bringing important therapies to patients in need.
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
Nice To Haves
- 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.
Responsibilities
- 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
- Prepare/review safety sections of periodic aggregate reports
- 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
- Inspection Readiness
Benefits
- health and welfare plans for staff and eligible dependents
- financial plans with opportunities to save towards retirement or other goals
- work/life balance
- career development opportunities
- 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, 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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What This Job Offers
Job Type
Full-time
Career Level
Director
