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! #J-18808-Ljbffr Vir Biotechnology, Inc.

Job Tags

Holiday work, Full time,

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