Pharmacovigilance

Pharmacovigilance

Drug Safety Monitoring

  • End-to-end ICSRs processing from intake to submission
  • Signal detection
  • Benefit / Risk balance assessment
  • Risk management : RMPs preparation, implementation, effectiveness assessment
  • Literature review
  • Medical writing : aggregate reports (PSUR, PBRER, PADER, DSUR), ad hoc response to Health & Regulatory Authorities inquiries
  • Safety monitoring & medical review in clinical trials

Customized Support to your Drug Safety projects

  • Insourced & outsourced temporary staffing of PV professionals
  • Drug safety database : implementation, data migration, validation & IT support
  • PV quality system & compliance support & oversight
  • Internal audit & Health Authority inspection preparation & support
  • Local & EU-QPPV representation
  • PSMF maintenance
  • PV training matrix development
  • Regulatory watch
  • Medical & scientific information
INDIA OUTSOURCING