Sr Medical Safety Advisor
IQVIA · Bangalore, India
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Senior Medical Safety Advisor role at IQVIA involving evaluation of adverse event safety data, medical review of trial and post-marketing reports, and leadership of pharmacovigilance activities. The position requires clinical expertise to assess safety profiles and collaborate with cross-functional teams on regulatory submissions and safety surveillance.
What they're looking for
- Medical degree from accredited, internationally recognized medical school
- Three years clinical medicine practice post-medical degree
- In-depth knowledge of GCP and ICH guidelines
- Pharmacovigilance knowledge including ICSR and aggregate reports
- Proficiency with safety databases and Microsoft Office applications
- Strong verbal and written communication skills
- Valid medical license from country or region of residence
What you'll be doing
- Review and clarify trial and post-marketing adverse events including causality and seriousness assessment
- Compose and edit Analyses of Similar Events for expedited regulatory cases
- Provide coding review and medical vetting of adverse event and clinical data
- Generate aggregate safety reviews including DSURs, RMPs, and regulatory reports
- Lead safety assessment activities and mentor other team members on pharmacovigilance issues
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.