Post-marketing Pharmacovigilance:

  • Drug Safety Project Management
  • Collection and follow-up of Adverse Drug Reactions (ADRs) originating from all post-market sources
  • Weekly literature searches of Medline
  • Electronic management of ADRs on the ARISg database
  • Electronic expedited reporting to Competent Authorities
  • Eudravigilance set up and management
  • EU Qualified Person for Pharmacovigilance (QPPV) and deputy QPPV oversight
  • Reconciliation with Medical Information
  • Compliance oversight
  • Signal Detection
  • 24 hour cover
  • Filing and archiving