Associate Medical Director, Drug Safety
About The Position
The Drug Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. The Drug Safety Physician will represent Biogen Safety in internal and external meetings. The Drug Safety Physician can be appointed as the Global Safety Officer for a specific product. Responsible for keeping upper management informed of safety issues. The Drug Safety Physician will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycle. This person will also interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.
Requirements
- MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred.
- Minimum 3+ years’ experience in the pharmaceutical industry or clinical care setting; ideally 1+ years of overall experience specific to pharmacovigilance.
- Prior experience in clinical trials; academic and/or industry.
- Knowledge of pre- and post- marketing US and EU regulations
Nice To Haves
- subspecialty focus in neuroscience, psychiatry, immunology, rare diseases
Responsibilities
- Manage safety surveillance for assigned products
- Collaborate with PV scientists and other stakeholders
- Conduct analyses of safety trial data.
- Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.
- Provide safety strategic leadership for clinical development programs
- Integrate the safety scientific component to build a strategic framework for clinical development plans.
- Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
