Pharmacovigilance services

We are reliable partner for complete pharmacovigilance process. Together with you, we develop individual solutions to set-up the optimal PV system tailored to your company size/product portfolio. We also help you to manage and monitor all routine safety aspects of your medicinal product(s).

Together with partners in countries worldwide we provide you with country-specific PV services.

Our services include but are not limited to

  • Establishing and managing the PV system
  • Acting as EU QPPV and local PV contact, 24/7 availability
  • Overview of the safety profile of medicines
  • Local processing of Individual Case Safety Reports
  • Handling of Periodic Safety Update Reports (PSUR)
  • Direct Healthcare Professional Communication, DHPC
  • PV auditing
  • Monitoring of published scientific and medical literature
  • Creation of Risk Management Plan (RMP) / custom-made RMP
  • Reporting to the European database EudraVigilance about suspected side effect
PV Services