Job 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). Youwill perform as a leader who is collaborative, a self-starter, 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 Safety Risk Management Team (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
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
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
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
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $250,000 to $329,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Virs compensation and benefits are aligned with the current market and commensurate with the persons experience and qualifications. All full-time employees receive a package that includes : compensation, bonus and equity as well as many other Vir benefits and perks such as : health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees!
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Job Tags
Holiday work, Full time,