Pharmacovigilance & device vigilance

Full-service outsourcing of adverse-event intake and processing and product complaint documentation, or select services to complement your existing drug safety operation, featuring:

  • Qualified Person for Pharmacovigilance (QPPV)
  • Documentation and analysis of case data
  • Preparation of periodic reports, such as Periodic Safety Update Reports (PSUR)
    and Annual Safety Reports (ASR) and ad hoc reports
  • Review of PSUR reports and providing of QPPV confirmation and Expert Opinion
  • Signal detection and risk-benefit analyses
  • Literature searches for case identification and reporting
  • Patient safety and risk management support
  • Training courses on PV and device vigilance regulations and procedures