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A World Without Infectious Disease
Senior Director – Global Pharmacovigilance, Risk Management
Location
United States
Posted
128 days ago
Salary
$235.5K - $329.5K / year
Seniority
Senior
Job Description
Senior Director – Global Pharmacovigilance, Risk Management
Vir Biotechnology, Inc.
• Chair cross-functional Safety Risk Management Team (SRMT) to review safety data from all sources to detect, evaluate, monitor, and minimize safety signals/risks • 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
Job 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
- 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 SRMT teams.
- Experience with global regulations and ICH guidance governing pharmacovigilance and risk management
- Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding
Benefits
- 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
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