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Pharmacovigilance

Pharmacovigilance - 2

With our highly experienced and committed pharmacovigilance team, “PV-Arena” database, and tailored pharmacovigilance solutions, we support our customers with the needed specialized patient safety and regulatory affairs services for all related pharmacovigilance activities.

Services

Our safety reporting management system “PV-Arena” is designed to be a reliable tool with the following features:

  • check-mark-1ICH E2B (R2) Reporting Support
  • check-mark-1MedDRA Browser Integration
  • check-mark-1XML Case Reporting
  • check-mark-1Signal Detection
  • check-mark-1Duplicate Check
  • check-mark-1Full Audit Trail
  • check-mark-1Integrated Document Management

Full Delegation or on-demand “Qualified Person of Pharmacovigilance (QPPV)/ Local Safety Reporter (LSR)”:

  • check-mark-1Risk Management Plans (RMP)
  • check-mark-1Pharmacovigilance System Master File (PSMF)
  • check-mark-1Processing Individual Case Safety Report (ICSR)
  • check-mark-1Ad-Hoc analysis
  • check-mark-1Periodic Benefit-Risk Evaluation Reports (PBRER)