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:

    • Local Israeli 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