Medical Director, Global Safety Lead
2 weeks ago
We are seeking a highly skilled Medical Director, Global Safety to join our team at Biogen. As a key member of our safety team, you will be responsible for overseeing the medical safety aspects of our products, ensuring compliance with regulatory requirements, and providing strategic leadership within our clinical development programs.
Key Responsibilities- Lead the medical review and approval of individual case safety reports (ICSRs) and aggregate reports.
- Develop and execute risk management strategies to ensure product safety and compliance with regulatory requirements.
- Provide strategic safety leadership within clinical development teams and collaborate with cross-functional program counterparts.
- Respond to safety queries from health authorities and contribute safety expertise to develop strategic frameworks for clinical development plans.
- Ensure compliance with adverse event reporting requirements for investigational and marketed products.
- MD with a subspecialty focus in kidney disease preferred.
- A minimum of 5+ years in the pharmaceutical industry or clinical care setting, with 3-5+ years dedicated to pharmacovigilance.
- Experience with clinical trial safety, signal evaluation, and risk mitigation.
- Familiarity with pre- and post-marketing safety regulations in the US and EU.
- Strong written and verbal communication skills and the ability to work effectively in a team.
- Leadership capabilities with strong problem-solving, conflict resolution, and analytical skills.
Biogen offers a competitive compensation package, including a base salary range of $186,000 - $309,000, as well as eligibility for participation in LTI grants and other incentive programs. We also offer a full range of benefits, including medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
We are an equal opportunity employer and welcome applications from diverse candidates. We are committed to building a culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
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