Senior Medical Director Safety & Pharmacovigilance

Job Description

Senior Director, Medical Safety & Pharmacovigilance

Remote with Travel

A commercial stage biotechnology company focused on developing innovative therapies for serious autoimmune and inflammatory diseases is seeking a Senior Director of Medical Safety & Pharmacovigilance. This individual will play a key role in strengthening safety and pharmacovigilance capabilities in support of commercial post launch and ongoing post-marketing activities.

The successful candidate will provide medical leadership and clinical oversight to ensure robust safety surveillance, regulatory compliance, and high-quality pharmacovigilance operations.

Key Responsibilities

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• Conduct medical review of Individual Case Safety Reports (ICSRs), including evaluation of case narratives, medical assessments, expectedness, and causality.
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• Provide medical expertise on complex, serious, and medically significant adverse event cases.
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• Support signal detection and ongoing safety surveillance activities through the review and interpretation of aggregate safety data.
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• Present and discuss safety findings in cross-functional safety governance meetings and review forums.
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• Perform quality review of safety data and ensure compliance with global pharmacovigilance regulations and reporting requirements.
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• Partner with Clinical Development, Regulatory Affairs, and other internal stakeholders to provide medical input on safety-related topics, including study protocols and investigator-facing documents.
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• Contribute to the development, maintenance, and continuous improvement of pharmacovigilance processes and documentation.
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• Interact with clinical investigators and external partners to obtain additional medical information and case follow-up as needed.
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• Support the preparation of safety narratives and other safety-related deliverables for clinical and post-marketing activities.
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Qualifications

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• MD, DO, or equivalent medical degree required.
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• Minimum of 2 years of experience in Drug Safety or Pharmacovigilance, including medical review of ICSRs.
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• Strong clinical judgment with demonstrated experience assessing causality, expectedness, and the medical significance of adverse events.
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• Experience collaborating with cross-functional teams and external investigators.
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• Prior experience supporting post-marketing safety activities preferred.
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• In-depth knowledge of global pharmacovigilance regulations, safety reporting requirements, and industry best practices.
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• Excellent communication, analytical, and problem-solving skills.
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Apply now to join a growing patient focused company!