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
