Medical Director, Global Safety

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Job description

Job Description

About This Role:

Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

We are seeking a Global Safety Officer to be a crucial member of our safety team, focusing on the medical safety aspects of our products. Your role will be instrumental in reviewing and analyzing safety data from various sources, including clinical studies and post-marketing settings. Tasked with overseeing signal assessments and ensuring the integrity of safety conclusions, you will provide strategic leadership within our clinical development programs. Moreover, you will manage safety surveillance and risk management strategies, ensuring our products' benefit-risk profiles are thoroughly assessed. Your expertise will further extend to regulatory filings and representing the safety team in key discussions, thereby directly contributing to the company's commitment to patient safety and regulatory compliance.

What You'll Do:

Serve as the safety officer for assigned products, providing oversight and analysis of safety data.

Oversee signal assessments and derive safety and benefit-risk conclusions from aggregate reports.

Lead the medical review and approval of individual case safety reports (ICSRs).

Ensure compliance with adverse event reporting requirements for investigational and marketed products.

Provide strategic safety leadership within clinical development teams.

Respond adeptly to safety queries from health authorities.

Contribute safety expertise to develop strategic frameworks for clinical development plans.

Develop and execute risk management strategies to ensure product safety.

Foster collaborative relationships with cross-functional program counterparts in various scientific and clinical domains.

Account for the accurate assessment of Benefit/Risk in Aggregate Reports.

This position is Hybrid based and travel to our South San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered.

Who You Are:

You are a medical doctor with a passion for patient safety and a keen eye for detail. Your analytical skills and experience in pharmacovigilance enable you to lead safety strategies and risk management with confidence and clarity. You thrive in cross-functional team environments and are committed to advancing healthcare through vigilant safety oversight.

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