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    Director, Global Pharmacovigilance and Risk Management - San Francisco, United States - Vir Biotechnology, Inc.

    Vir Biotechnology, Inc.
    Vir Biotechnology, Inc. San Francisco, United States

    1 week ago

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    Description

    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

    #LI _AA1
    #LI-Remote


    WHO WE ARE AND WHAT WE OFFER


    The expected salary range for this position is $194,000.00 to $284, Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

    Vir's compensation and benefits are aligned with the current market and commensurate with the person's 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
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