Vir Biotechnology is hiring a
Senior Director, Global Pharmacovigilance & Risk Management

Summary

Vir Biotechnology is hiring a Senior Director for their Global Pharmacovigilance & Risk Management (PVRM) Medical Safety department. The role involves providing medical expertise in signal management, risk management, and monitoring the safety profile of Vir products. The position is remote and requires a medical degree or PharmD with at least 2 years of experience in clinical/medical practice and 10+ years of related experience.

Requirements

• Medical degree (MD/DO), PharmD, or equivalent required, with at least 2 years of experience in clinical/medical practice
• 10+ years of related experience; experience in global pharma/biotech is preferred

Responsibilities

• Chair cross-functional Safety Risk Management Team (SRMT) to review safety data from all sources to detect, evaluate, monitor, and minimize safety signals/risks; to provide strategies for risk management/mitigation and develop Risk Tracking Document and RMP; to evaluate the Benefit-Risk profiles of Vir products
• Contribute to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms, IB Reference Safety Information, Publications, and other relevant documents
• 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
• 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
• Provide leadership in regulatory authority interactions regarding safety and risk management
• Support the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities
• Assist in the maintenance of Global PVRM related cross-functional SOPs in compliance with global safety regulations and guidelines and lead corporate initiatives and inspection readiness

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
• Lunch for all onsite employees