Medical Director/Senior Medical Director, Pharmacovigilance

Responsibilities

• Lead and support PV Scientist(s) through direct management, mentorship, and guidance.
• Conducts medical review of reports of adverse events, special situations, and other safety information including assessments, review of coding using MedDRA and WHO Drug, and review of the narratives for medical completeness and accuracy.
• Lead the Safety Management Team and safety governance / escalation processes.
• Collaborate within PV and cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, CMC, Quality, and other stakeholders to identify, evaluate, and manage safety signals, including participation in Health Hazard Assessments and risk management activities.
• Contribute medical expertise to product labeling including Company Core Data Sheets (CCDS); lead determination of the Adverse Reactions sections and contribute to other safety-relevant labeling updates.
• Lead signal detection activities including oversight of activities performed by PV Scientist(s) and vendor(s).
• Provide medical review and oversight of aggregate safety reports, including PSURs, PBRERs, DSURs, ASRs, and integrated safety summaries.
• Provide expert medical advice across programs and contribute to strategic safety planning to support timely and high-quality delivery of clinical and commercial objectives.

Qualifications

• MD or DO is required.
• Additional advanced degree (for e.g. MPH, PhD) is a plus.
• 10 plus years of relevant experience in drug safety, clinical safety and/or benefit-risk management within the biotechnology or pharmaceutical industry.
• Patient care experience preferred, with experience in infectious disease or critical care a plus.
• Strong understanding of pharmacovigilance regulations in the US and EU, Good Pharmacovigilance Practices, .
• Strong drug safety database and MedDRA coding experience required.