Medical Director, Global Medical Safety

Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor. May represent Biogen Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound / product. The successful candidate 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 life cycle. The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.

• Manage safety surveillance for assigned compounds / products a. Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals. b. Conduct analysis of safety data. c. Ensure adequacy of recording, 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 / program teams a. Integrate the safety scientific component to build a strategic framework for clinical development plans.
• Develop and maintain relationships with program 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 time frames and time frames dictated by regulatory authorities.
• If applicable, manage Associate Medical Director(s) overseeing their activities for assigned compounds/products.
• Minimum 7 years experience in the pharmaceutical industry or clinical care setting.
• Preferably has prior experience in pharmacovigilance or clinical development.
• Knowledge of pre- and post- marketing US and EU regulations
• Knowledge of clinical

A Medical Director in our Global Medical Safety organizatoin has broad responsibility for global pharmacovigilance for marketed and/or investigational products. Strong communication skills, scientific acumen, and the ability to work across the development functions are key traits for a Medical Director in this group. There is a strong strategic component along with visibility across R&D.