Added
less than a minute ago
Location
Type
Full time
Salary
Upgrade to Premium to se...
Related skills
pharmacovigilance mdr meddra device vigilance eudravigilance📋 Description
- Pharmacovigilance and device vigilance case intake, triage, and ICSR processing
- Evaluate adverse events from diagnostic use and assess clinical impact
- Coordinate medical review and causality assessment of adverse events
- Submit safety reports on time (MedWatch, EudraVigilance, CIOMS)
- Support aggregate PV reporting (PSUR/PBRER, DSUR, annual reports)
- Maintain global PV compliance with FDA, EMA, ICH, and IVDR
🎯 Requirements
- Bachelor’s degree in life sciences; advanced degree preferred.
- Minimum 12 years PV and/or device vigilance experience.
- Strong knowledge of FDA/EMA/ICH and EU IVDR regulations.
- Experience with PV databases (AEMS, Argus, ARISg, Veeva Safety).
- Familiarity with MedDRA coding and case processing workflows.
- ISO 13485 and ISO 14971 knowledge.
🎁 Benefits
- Comprehensive medical, dental, vision, life and disability plans
- Free genetic testing for employees and fertility care benefits
- 401k, commuter benefits and referral program
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Healthcare Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!