Senior Director, Global Pharmacovigilance and Risk Management-Head of Medical Sa

Vir Biotechnology, Inc. 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. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies.We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results.THE OPPORTUNITYVir Biotechnology is seeking an experienced Senior Director to be the Head of our Medical Safety function. Within Vir’s Global Pharmacovigilance & Risk Management (PVRM) department, you will provide medical expertise and strategic direction while overseeing the medical safety team, including responsibility for signal management, risk management, and monitoring the safety profile of Vir products. You will shape the strategy and 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, and risk management of Vir products. You will seek to optimize and implement approaches to support the scientific evaluation of the safety risk profile of Vir products. You will collaborate cross-functionally with colleagues in Clinical Research & Development, Clinical Operations, Clinical Pharmacology, Biometrics, Regulatory Affairs, Medical Affairs, non-clinical safety, QA, and Legal teams.This Senior Director, Global PVRM Medical Safety will perform as a hands-on team leader who is collaborative, a self-starter, and able to work in a matrixed environment. You will report to the Vice President, Global Pharmacovigilance & Risk Management.This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.What You’ll DoDevelop talent and provide leadership to Global PVRM Medical Safety teamProvide strategic planning, implementation, and management of Global PVRM Medical Safety activitiesProvide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulationsSupport inspection readiness and provide expertise in audits, inspections, and CAPAsResponsible for development of Global PVRM Medical Safety related procedural documentsRepresent Global PVRM Medical Safety as a leader on project teams and committeesLead Safety Review Management Team to address any safety-related issues for Vir products, 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, Company Core Data Sheets, and local labels for Vir productsContribute to safety related sections of clinical study documents (e.g., Study Protocols, Informed Consent Forms, Statistical Analysis Plans, Clinical Study Reports, IB Reference Safety Information, Summary of Clinical Safety, Integrated Clinical Safety, Publications, Manuscripts)Perform medical review of Individual Case Safety ReportsPerform medical review and analysis for aggregate safety reports and responses to ad-hoc requests for safety informationProvide leadership in regulatory authority interactions regarding safety and risk managementLead the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activitiesWho You Are And What You BringMedical degree (MD/DO) or equivalent required, with at least 2 years of experience in clinical/medical practice and 8+ years of experience in pharmacovigilance leadership rolesExperience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSIExperience with signal detection process and managing safety information from clinical development and post-marketing sourcesExperience with Global regulations and ICH guidance governing pharmacovigilance and risk managementKnowledge of drug development process, pharmacovigilance databases, and MedDRA codingMust have demonstrable experience in people management at a leadership level and well-developed skills in team building, motivating, empowering, and developing talentWho We Are And What We OfferThe expected salary range for this position is $225,000 to $370,000. 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 each day in the office.Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.Vir Biotechnology (“Vir”) is an equal opportunity employer. All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.For hires based in the United States, Vir Biotechnology, Inc., participates in E-Verify.

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