Medical Director, Pharmacovigilance

Replimune is seeking a Medical Director, Pharmacovigilance to perform medical safety information assessment, signal detection, and benefit/risk management activities for Replimune's developmental and marketed products. The ideal candidate will have a strong background in pharmacovigilance, medical assessment, and signal detection, with experience in the pharmaceutical/biotech industry. The role can be based in Woburn, MA, or be a remote position.

Requirements

• Perform individual case safety report review
• Support the safety team and identify system and resource needs
• Contribute to risk management and benefit-risk evaluation
• Assure consistency and accuracy of medical assessments
• Lead aggregate safety data reviews and prepare medical content of periodic reports
• Ensure safety profiles of Replimune products are accurately represented in labeling documents
• Contribute to preparation and delivery of safety information for regulatory submissions
• Support development of medical sections of responses to safety related health authority requests
• Organize and participate in periodic PSRC meetings to review aggregate safety information and signal management
• Perform medical review of individual case safety reports (ICSRs)
• Educate pharmacovigilance colleagues and others on medical assessment, signal detection, and safety risk management practices
• Identify opportunities and manage continuous improvement initiatives
• Actively interact with external customers and service providers
• Contribute to development and/or updates of relevant procedural documents
• Provide medical safety expertise for internal and external audits and regulatory authority inspections
• Maintain up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally

Benefits

• Medical, dental, and vision insurance
• 401k match
• Flexible time off
• Paid holidays including year-end shutdown