The monitoring, detection, collection, assessment and prevention of adverse effects of pharmaceutical products and Medical Devices are essential elements to ensure patients’ safety and wellbeing.
The Europital team of Pharmacovigilance (PV) scientists together with our safety physicians support Pharmaceutical, Biotech and Medical Device companies to ensure patients’ safety and meet regulatory requirements via the appropriate setup and implementation of all aspects of PV.
- Setup, Managing and Maintaining Safety Database
- Adverse Event management and expedited reporting
- ICSR Processing and Reporting
- Aggregate Safety Reports preparation and submission
- Literature Search
- Risk Management
- Eudravigilance setup, registration and reporting
- EU QPPV
- Pharmacovigilance System Master File Management
- Medical Device Vigilance