Safety Reporting & Pharmacovigilance

Our Pharmacovigilance team has global experience in safety reporting in clinical trials and post marketing surveillances. Our team consists of highly educated, professional with medical, pharmacology background and having in-depth knowledge in using various safety databases, safety reporting requirements, Pharmacovigilance regulations and guidelines.

Pharmacovigilance Services PV Writing services
  • Case intake
  • Case triage
  • Case processing
  • Medical coding
  • Case narration
  • Quality checks
  • Case assessment
  • Medical review
  • Completion of MedWatch Form/CIOMS Form Electronic submissions
  • Periodic Safety Update Reports (PSUR) writing
  • PADER/PBRERs/Aggregate reporting
  • DSUR writing