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

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. 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.