Pharmacovigilance Services

  • Safety Data Management

  • Case acknowledgement

  • Creating ICSR (individual case study report)

  • Data Entry

  • Duplication of AE search

  • AE and Drug Coding

  • SAE Reconciliation

  • Query Management

  • Case prioritization

  • Case narrative

  • Safety assessment

  • Reporting to authorities

  • Signal detection

  • Risk Mitigation plans

  • Aggregate report and Periodic safety report writing and submission such as PSUR, PADER etc