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