Pharmacovigilance


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