Pharmacovigilance

• QPPV/Local Contact Person/PVQA services
• Periodic documentation drafting:
  • Periodic Safety Update Report (PSUR) drafting
  • Risk Management Plan (RMP) development
  • Management of the Pharmacovigilance system and Pharmacovigilance System Master File (PSMF)
  • Signal detection activities
• Global literature and regulatory websites monitoring
• ICSR management
• Data Entry and Maintenance of the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)
• Support for pharmacovigilance in clinical trials