Senior Director, Global Pharmacovigilance & Risk Management-Medical Safety

Vir Biotechnology, Inc.; San Francisco (CA); Remote; USD 250,000 - 329,000; Full time

Job summary

An established industry player is seeking a Senior Director to lead the Global Pharmacovigilance & Risk Management team. This remote position offers the opportunity to shape safety strategies for innovative products from development through post-marketing. The ideal candidate will possess a medical degree and extensive experience in pharmacovigilance, demonstrating leadership in cross-functional teams and regulatory interactions. With a competitive salary and comprehensive benefits, this role is perfect for those looking to make a significant impact in the field of medical safety.

Benefits

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Non-accrual paid time off

Commuter benefits

Child care reimbursement

Education reimbursement

401K match

Qualifications

• 10+ years of experience in global pharma or biotech preferred.
• Expertise in authoring safety signal assessment reports and managing safety information.

Responsibilities

• Lead cross-functional Safety Risk Management Team to evaluate safety signals.
• Provide leadership in regulatory authority interactions regarding safety.

Skills

Signal management

Risk management

Clinical study documentation

Regulatory authority interactions

Pharmacovigilance agreements

Education

Medical degree (MD / DO) or PharmD

Experience in clinical / medical practice

Tools

MedDRA coding

Pharmacovigilance databases

Job description

Vir Biotechnology is seeking an experienced Senior Director, within the Global Pharmacovigilance & Risk Management (PVRM) Medical Safety department. The Senior Director will provide medical expertise in signal management, risk management, and monitoring the safety profile of Vir products (from First-In-Human through post-marketing). Youwill perform as a leader who is collaborative, a self-starter, 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 Safety Risk Management Team (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
• Contribute to safety related sections of clinical study documents including Study Protocols, Informed Consent Forms, IB Reference Safety Information, Publications, and other relevant documents
• Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing global regulations
• Support inspection readiness and provide expertise in audits, inspections, and CAPAs
• Perform medical review of Individual Case Safety Reports
• Perform medical review and analysis for aggregate safety reports and responses to ad-hoc requests for safety information
• Provide leadership in regulatory authority interactions regarding safety and risk management
• Support the negotiation of safety data exchange / pharmacovigilance agreements with license partners and distributors for drug safety and risk management related activities
• Assist in the maintenance of Global PVRM related cross-functional SOPs in compliance with global safety regulations and guidelines and lead corporate initiatives and inspection readiness

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
• 10+ years of related experience; experience in global pharma / biotech is preferred
• Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI
• Experience with signal detection process and managing safety information from clinical development and post-marketing sources
• Experience leading cross-functional SRMTs teams.
• Experience with global regulations and ICH guidance governing pharmacovigilance and risk management
• Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding

WHO WE ARE AND WHAT WE OFFER

The expected salary range for this position is $250,000 to $329,000. 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 for all onsite employees!