Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV.
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. We are proud to be the first company to be ranked at the top of the Deloitte Fast 500 list two years in a row (2023 & 2022)!
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
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $194,000.00 to $284,000.00. 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!
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.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
For hires based in the United States, Vir Biotechnology, Inc., participates in E-Verify.
