Vir is a clinical-stage immunology company with a compelling mission; "A World Without Infectious Disease". We are focused on combining immunologic insights with innovative technologies. We have assembled four technology platforms that are designed to stimulate and improve the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product individuals targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
The Director of Pharmacovigilance encompasses a key role in setting and executing departmental strategy and in managing the day-to-day functioning of Drug Safety. This role collaborates with colleagues/vendors in Clinical Research, Clinical Operations, Biometrics, Regulatory, QA and Legal. The successful candidate will be the inaugural member of the Safety function at Vir and establish the infrastructure and key processes required to enable successful development of the company's therapeutic programs, ensuring corporate compliance with all applicable US and foreign legal and regulatory requirements for signal detection, evaluation & risk management of medicinal products.
They will perform as a hands-on leader who is collaborative, a self-starter, and has the ability to work in a matrixed environment. This position reports to the Vice President of Pharmacovigilance.
- Sets Corporate direction for drug safety and pharmacovigilance activities for ensuring Corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.
- Establishes the Pharmacovigilance Department direction, standards, and processes for supporting Corporate safety monitoring activities
- Manages the process for identifying, evaluating, and managing outsourcing vendors (eg, CROs, safety DB vendors)
- Oversees the activities of outsourcing vendors (eg, CROs, safety DB vendors) and individuals contracted to perform safety science activities
- Oversees the activities for monitoring patient safety, e.g., adverse event reports for potential safety related issues and provides recommendations when potential issues are identified
- Ensures that all safety reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures
- Performs Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database
- Liaises with Medical Monitors in Clinical Research to ensure that appropriate medical review and assessment is provided for adverse event reports received and non clinical safety findings reported
- Liaise with Medical Monitors in the analysis, identification and reporting or possible trends and concerns regarding Vir products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
- Leads the development of safety surveillance and risk management plans for drug development programs
- Provides leadership and assists in the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc)
- Leads the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors in support of process definition, monitoring and other roles as required by drug safety to perform the drug safety mission
- Assists in the preparation and revision of company product labeling as appropriate.
- Assists in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other.
- Facilitates and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs
- Collaborates with, and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives
- Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs
- Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems
- Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development
- 6+ years of experience in the pharmaceutical industry and a minimum of 6 years in leadership positions in drug safety and pharmacovigilance in the clinical trial environments.
- A minimum of 4 years of project or line management experience overseeing PV staff and/or consultants/CROs
- Medical Degree (MD, DO, or PharmD) is required
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, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
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.