Pharmacovigilance

  • Registering Sponsors and Marketing Authorization Holders with EudraVigilance
  • Electronic reporting of reportable Individual Case Safety Reports (ICSRs) to EudraVigilance
  • Extended EudraVigilance medicinal product dictionary (XEVMPD) entry and maintenance
  • Preparation of safety texts for study protocols and CSRs
  • Safety Management Plans development
  • Aggregate reports preparation (Development Safety Update Reports- DSURs, 6-Month SUSAR Reports, Periodic Safety Update Reports – PSURs)
  • SAE forms and other reporting forms and forms’ completion guidelines development
  • Pharmacovigilance SOPs development
  • ICSR narratives development
  • Continuous oversight of key performance indicators and metrics
  • Continuous vendor evaluations throughout the project
  • Pharmacovigilance training
  • SAE reporting
  • AE coding and grading