Pharmacovigilance Services
Here is a list of the pharmacovigilance services that are offered by PrimeVigilance. Of course this list is not exhaustive and thanks to the expertise and knowledge of our highly experienced staff, we are able to customize any pharmarmacovigilance services to your requirements.
(click on each triangle for further details or hover over the menu on the left for more information):
- Infrastructure and Database
- Individual Case Safety Report (ICSR) processing
- Expedited reporting, including Eudravigilance
- Clinical trial SAE / SUSAR management
- Periodic reporting, including ASRs and PSURs
- Literature screening and review
- EU Qualified Person for Pharmacovigilance (QPPV)
- Detailed Descriptions of PV Systems (DDPS)
- Risk Management Plans (RMP)
- Training
- Audits
- Safety Data Exchange Agreements
- Signal Detection and evaluation; advice on safety issues
- Responding to enquiries from Authorities
- Identifying and communicating changes to Risk / Benefit
For more information contact PrimeVigilance today
PrimeVigilance
in conjunction with Elliot Brown Consulting and Ergomed