PHARMACOVIGILANCE


As a local pharmacovigilance representative of the Client, ADAX provides monitoring of medicinal product’s safety:

  • Qualified Person for Pharmacovigilance (QPPV) or Local Safety Officer (LSO)
  • 24/7 availability for AE reporting
  • Pharmacovigilance system set up and maintenance
  • Reporting of Individual Case Safety Reports (ICSRs) into EudraVigilance
  • Pharmacovigilance System Master File (Including PV Summary)
  • Product registration tracking (XEVMPD, IDMP)
  • Safety signal management and Risk Management Plan
  • Pharmacovigilance Quality Management set-up and maintenance for Manufacturers
  • Regular monitoring of Scientific Literature