Pharmacovigilance

Pharmacovigilance

Pharmacovigilance at Adveesan Consulting offers a broad range of services including:

  • PV Medical Writing Services
    • Periodic Benefit-Risk Evaluation Report (PBRER)
    • Periodic Safety Update Report (PSUR)
    • Periodic Adverse Drug Experiences Report (PADER)
    • Risk Management Plan (RMP)
    • Annual Safety reports
  • Literature search and Case processing, Signal Detection
  • Company Core Data Sheets (CCDS) updates
  • Summary of Product Characteristics (SmPC) review and updates
  • Qualified Person for Pharmacovigilance (QPPV) services in Europe
  • Pharmacovigilance set up and management
  • Pharmacovigilance Audits and Gap Analysis