Pharmacovigilance


  • Medical monitoring (office hours or 24/7)
  • Safety management plans
  • Medical monitoring plans
  • Medical coding (MedDRA and ATC)
  • Medical review, safety documents, clinical study protocols and reports
  • SAE case surveillance, processing and tracking
  • Causality and expectedness assessments of SAE, case narratives preparation
  • CIOMS form preparation
  • Expedited SUSAR reporting
  • Development safety update reports (DSURs)
  • Data monitoring committee (DMC) setup, management and participation
  • MEDDEV safety reporting