Pharmacovigilance

  • Our QPPVs provide general pharmacovigilance consultancy in addition to the QPPV oversight role and can effectively advise on additional PV, risk management plan/risk minimization activities over the lifecycle of your product.
  • QW has extensive experience in Pharmacovigilance System Master File (PSMF) and PV Safety Data Exchange Agreements (SDEA) authoring, optimization and management ensuring efficiencies in negotiating and complying with PV Agreements (PVAs).
  • QW provides following PV services for your pharmaceutical producsts
  • Safety and medical writing
  • Literature surveillance
  • Signal management
  • Risk management plan
  • Local contact person for pharmacovigilance