Associate Medical Safety Director

IQVIA

Multiple Locations
Medical expertise in pharmacovigilance
Review adverse events and drug reactions
Aggregate safety information review
Provide medical expertise on pharmacovigilance services, performing medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions

Job Summary

  • Provide medical expertise on pharmacovigilance services, performing medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions.
  • Compose, edit, and medically review various regulatory reports including IND Annual Reports, Periodic Benefit Risk Evaluation Reports, and Risk Management Plans.
  • Serve as an internal consultant to pharmacovigilance case processing teams and provide medical oversight for label development and Data Safety Monitoring Board Meetings.

Matching Summary

Provide medical expertise on pharmacovigilance services, performing medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions.

Skills & Requirements

Must-have

  • Medical expertise in pharmacovigilance
  • Review adverse events and drug reactions
  • Aggregate safety information review
  • Client-facing safety representation
  • Regulatory reporting and documentation

Nice-to-have

  • Internal consultant to case processing
  • Contribute to safety monitoring committees
  • Maintain industry awareness
  • Initiative and flexibility

Key Requirements

  • 7+ years clinical practice experience
  • 9+ years pharmaceutical industry experience
  • Medical degree from accredited school
  • Valid medical license
  • Knowledge of clinical trial regulations

Work Rights

Not specified

Tailored Resume

Cover Letter