[Hiring] Senior Director. Global Pharmacovigilance & Risk Management @Vir Biotechnology

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Role Description

Vir Biotechnology is seeking an experienced Senior Director, within the Global Pharmacovigilance & Risk Management (PVRM) Medical Safety department. The Senior Director will provide medical expertise in signal management, risk management, and monitoring the safety profile of Vir products (from First-In-Human through post-marketing). You will perform as a leader who is collaborative, a self-starter, and able to work in a matrixed environment.
• Chair cross-functional Safety Risk Management Team (SRMT) to review safety data from all sources to detect, evaluate, monitor, and minimize safety signals/risks
• Provide strategies for risk management/mitigation and develop Risk Tracking Document and RMP
• 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
• Lead corporate initiatives and inspection readiness

Qualifications
• 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
• Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI
• Experience with signal detection process and managing safety information from clinical development and post-marketing sources
• Experience leading cross-functional SRMTs teams
• Experience with global regulations and ICH guidance governing pharmacovigilance and risk management
• Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding

Benefits
• The expected salary range for this position is $235,500 to $329,500
• Compensation, bonus and equity aligned with the current market
• Health and welfare benefit plans
• Non-accrual paid time off
• Company shut down for holidays
• Commuter benefits
• 401K match
• Lunch each day in the office

Company Description

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.

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