Ivowen provides a range of pharmacovigilance services for marketing authorisation holders such as:
- Act as a QPPV (Qualified Person Responsible for Pharmacovigilance)
- Register your company with EudraVigilance
- Processing of ICSRs (Individual Case Safety Reports)
- Reporting via EudraVigilance
- Literature screening and review
- Preparation and maintenance of Risk Management Plans (RMPs)
- Preparation of PSURs (Periodic Safety Update Reports)
- Signal Detection and evaluation
- Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
