- 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.
- MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred
- Minimum 2+ 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
- Strong communication skills, scientific acumen, and the ability to work across the development functions are key traits for a Medical Director in this group.
- Capacity and willingness to work effectively across disease areas
- The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills
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Medical Director, Drug Safety - Cambridge, United States - Biogen
Description
Job Description
The following information aims to provide potential candidates with a better understanding of the requirements for this role.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
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.
Qualifications
Required Skills
#LTD-1
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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