Global Pharmacovigilance Strategic Director

1 week ago


California, Missouri, United States Vir Biotechnology, Inc. Full time
Job Summary

This Senior Director role is crucial in leading the Medical Safety function at Vir Biotechnology, Inc. The ideal candidate will provide medical expertise and strategic direction, overseeing the medical safety team and ensuring compliance with all applicable regulations.

Key Responsibilities
  • Develop and implement strategic plans for Global Pharmacovigilance and Risk Management activities
  • Lead the medical safety team in signal management, risk assessment, and monitoring the safety profile of Vir products
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Develop and maintain procedural documents for Global Pharmacovigilance and Risk Management
  • Represent the Medical Safety function in project teams and committees
  • Perform medical review of Individual Case Safety Reports and aggregate safety reports
  • Lead regulatory authority interactions and negotiate safety data exchange/pharmacovigilance agreements
Requirements
  • Medical degree (MD/DO) or equivalent required
  • At least 2 years of clinical/medical practice experience and 8+ years of pharmacovigilance leadership experience
  • Experience in authoring safety signal assessment reports and managing safety information from clinical development and post-marketing sources
  • Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding
  • Proven leadership skills in team building, motivating, and developing talent
About Vir Biotechnology, Inc.

Vir Biotechnology, Inc. is a biotechnology company dedicated to addressing infectious diseases and cancer. The company is seeking an experienced Senior Director to lead the Medical Safety function in ensuring the safety and efficacy of its products.



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