Senior Director Global Pharmacovigilance Risk Management Head of Medical Safety

Summary

Vir Biotechnology is seeking an experienced Senior Director to lead its Medical Safety function. The position involves overseeing the medical safety team, providing strategic direction, and ensuring compliance with legal and regulatory requirements for Vir products. This is a remote position within the United States.

Requirements

• Medical degree (MD/DO), PharmD, or equivalent required, with at least 2 years of experience in clinical/medical practice
• 13+ years of related experience with 8+ years leading Safety Teams

Responsibilities

• Develop talent and provide leadership to Global PVRM Medical Safety team
• Provide strategic planning, implementation, and management of Global PVRM Medical Safety activities
• Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulations
• Support inspection readiness and provide expertise in audits, inspections, and CAPAs
• Responsible for development of Global PVRM Medical Safety related procedural documents
• Represent Global PVRM Medical Safety as a leader on project teams and committees
• Lead Safety Review Management Team to address any safety-related issues for Vir products
• Contribute to safety related sections of clinical study documents
• Perform medical review of Individual Case Safety Reports
• Perform medical review and analysis for aggregate safety reports and responses to ad-hoc requests for safety information
• Lead the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities

Benefits

• Health, dental, vision, life and disability insurance benefits
• Non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees