Senior Director Pharmacovigilance Risk Management

Location: Remote
Compensation: Salary
Staff Reviewed: Wed, May 15, 2024
This job expires in: 16 days

Job Summary

A company is looking for a Senior Director, Global Pharmacovigilance & Risk Management-Medical Safety.

Key Responsibilities:
  • Chair cross-functional Safety Risk Management Team (SRMT) to review safety data and develop risk management strategies
  • Contribute to safety-related sections of clinical study documents and provide expert guidance internally and externally
  • Perform medical review of Individual Case Safety Reports and aggregate safety reports

Qualifications:
  • Medical degree (MD/DO), PharmD, or equivalent with 2 years of clinical/medical practice experience
  • 10+ years of related experience in global pharma/biotech preferred
  • Experience in authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI
  • Experience with global regulations and ICH guidance in pharmacovigilance and risk management
  • Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding

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