Senior Director. Global Pharmacovigilance & Risk Management

Role Summary

Senior Director, Global Pharmacovigilance & Risk Management (PVRM) leads medical safety activities for products from first-in-human to post-marketing. The role provides medical expertise in signal management and risk management, and oversees monitoring of safety in a matrixed environment, partnering across functions to ensure safe and compliant product profiles.

Responsibilities

• Chair cross-functional Safety Risk Management Team (SRMT) to review safety data from all sources to detect, evaluate, monitor, and minimize safety signals/risks; provide strategies for risk management/mitigation and develop Risk Tracking Document and RMP; 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 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

Qualifications

• Required: Medical degree (MD/DO), PharmD, or equivalent, with at least 2 years of experience in clinical/medical practice
• Required: 10+ years of related experience
• Preferred: Experience in global pharma/biotech
• Required: Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI
• Required: Experience with signal detection process and managing safety information from clinical development and post-marketing sources
• Required: Experience leading cross-functional SRMTs teams
• Required: Experience with global regulations and ICH guidance governing pharmacovigilance and risk management
• Required: Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding

Skills

• Medical safety and pharmacovigilance expertise across development and post-marketing
• Leadership and ability to drive cross-functional collaboration in a matrixed environment
• Regulatory affairs knowledge and experience with safety inspections/audits
• Medical review of safety data and aggregate safety analyses
• Experience negotiating safety data exchange agreements and leading risk management initiatives

Education

• Medical degree (MD/DO), PharmD, or equivalent