Medical Director, Drug Safety

Found in: Resume Library US A2 - 2 weeks ago

Cambridge Massachusetts, United States Biogen Full time
Job Description

About This Role

The Medical Director, Drug Safety is 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 a 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.

What You’ll Do

Manage safety surveillance for assigned products and 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 building 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, and 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.

Who You Are

You 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 the 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.

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