Associate Medical Director, Drug Safety

About This Role

The Associate Medical Director in our Global Medical Safety organization is responsible for global pharmacovigilance for marketed and/or investigational products. Including the review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, and management of benefit-risk profile for assigned compounds and products. This role will work to keep upper management informed of safety issues and may work with clinical programs as a medical advisor, and may represent Biogen Drug Safety and Risk Management at internal and external meetings.

The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and 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, and global regulatory authorities.

What You’ll Do

• In cooperation with a PV scientist, manage the collection of current data for safety signaling and identify and investigate safety signals.
• Analyze safety data and monitor safety surveillance for assigned compounds/products.
• Ensure adequacy of recording, summarizing, and handling adverse events for investigational and/or marketed Biogen products.
• Provide strategic safety leadership for clinical development programs and teams and 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, and 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.

Who You Are

You demonstrate the flexibility and capability to function at a high level across multiple disease areas and can successfully work in an entrepreneurial environment to advance compounds' safety and biological understanding through the life cycle. You can build relationships and positively interact with multiple levels of management within Biogen, external stakeholders in the medical community, and global regulatory authorities.

Biogen is open to considering global candidates.

#LI-DR1

• MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred
• Minimum 5 years experience in the pharmaceutical industry or clinical care setting
• Ideally, 1 - 5 years of overall experience specific to pharmacovigilance. Prior experience in clinical trials; academic and/or industry preferred
• Knowledge of pre-and post-marketing US and EU regulations with the capacity and willingness to work effectively across disease areas
• Excellent communication skills (oral and written) and excellent organizational skills
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.