A World Without Infectious Diseases
The Senior Director, PVRM Physician will provide medical expertise in signal management, risk management, and monitoring the safety profile of Vir products. You will 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. This PVRM Physician leads and chairs cross-functional Safety Review Team meetings, and collaborates with colleagues in Clinical Research & Development, Clinical Operations, Clinical Pharmacology, Biometrics, Regulatory Affair, Medical Affair, non-clinical safety lead, QA and Legal departments.
This PVRM Physician will perform as a hands-on leader who is collaborative, a self-starter, and able to work in a matrixed environment. This position reports to the Vice President, Head of Global Pharmacovigilance & Risk Management.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Chair cross-functional Safety Review Teams (SRT) 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 SRT to address any safety-related issues for Vir products throughout product lifecycle from First-in-Human (FIH) 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 (CCDS), and local labels for Vir products
- Provide input to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis
- Plans (SAP), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, Manuscripts, and other relevant documents
- Perform medical review of Individual Case Safety Reports (ICSR) including fields such as case narrative, MedDRA coding, labeling, causality and company comment
- Perform medical review and analysis for Aggregate Safety Reports (ASR) 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
- Lead the negotiation of safety data exchange/pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities
- Assist the Head of PVRM to prepare and maintain PVRM and safety related cross-functional SOPs in compliance with the global safety regulations and guidelines, lead corporate initiatives and inspection readiness, and provide trainings
QUALIFICATIONS AND EXPERIENCE:
- Medical degree (MD/DO) required, with at least 2 years’ experience in clinical/medical practice
10+ 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
- Experiences in authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
- Skills in signal detection process and managing safety information from clinical development and post-marketing sources
- Experience with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
- Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
- Familiarity with Argus
deliver high quality work, and able to collaborate within PVRM and throughout the company
- High degree of Emotional Intelligence, with excellent interpersonal, self-leadership and influencing skills
- Ability to travel as needed (typically 4-5 times per year)
- Can do attitude and ability to take on other tasks as assigned
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 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.