[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.
Apply Now
Apply Now
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.
Apply Now
Apply Now