Director, Global Pharmacovigilance and Risk Management (PVRM) Medical Safety

THE OPPORTUNITY

Vir Biotechnology seeks a Director, Global PVRM Medical Safety to provide medical input in signal management, risk management, and monitoring of the safety profile for Vir products. You will help implement pharmacovigilance and risk management activities throughout the product lifecycle (from first-in-human through post-marketing), assessing benefit-risk profiles, and ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for signal detection, evaluation & risk management of Vir products. You will support or lead cross-functional Safety Review Management Teams (SRMT) and collaborate with colleagues in different departments. As the Director, Global PVRM Medical Safety, you will be a leader who is collaborative and able to work in a matrixed environment.

This is a remote position. Vir only supports employees within the United States and reserves the right to approve work locations.

WHAT YOU'LL DO

• Chair cross-functional 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
• Lead SRMT, for Vir products, throughout product lifecycle from First-in-Human to post-marketing, including safety monitoring in clinical trials, safety assessment for potential signals/risks, responses to Health Authority requests, strategic guidance during NDA/BLA submissions, and creating and maintaining core safety information in Investigator Brochures (IB), Company Core Data Sheets, and local labels for Vir products
• Provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms, Statistical Analysis Plans, Medical Monitoring Plans, Clinical Study Reports, IB Reference Safety Information (RSI), Summary of Clinical Safety, Integrated Clinical Safety, Publications, Manuscripts, and other relevant documents
• Perform medical review of Individual Case Safety Reports, including fields such as case narrative, MedDRA coding, labeling, causality, and company comment
• Perform medical review and analysis for Aggregate Safety Reports such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Reports, and responses to ad-hoc requests for safety information
• Help negotiate safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities
• Assist in the maintenance of PVRM and safety related cross-functional SOPs in compliance with global safety regulations and guidelines, lead corporate initiatives and inspection readiness, and provide training

WHO YOU ARE AND WHAT YOU BRING

• Medical degree (MD/DO), PharmD, or equivalent required, with at least 2 years of experience in clinical/medical practice
• 8+ years of pharmaceutical industry experience in drug safety & pharmacovigilance for products in the clinical trial and post-marketing environments; experience in global pharma/biotech is preferred
• Experience in authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
• Experience with signal detection process and managing safety information from clinical development and post-marketing sources
• Experience with global regulations and ICH guidance governing pharmacovigilance and risk management
• Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
• Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
• Familiarity with safety databases