The Drug Safety Unit has extensive experience in managing all aspects of drug safety/pharmacovigilance services, from the drug development phase through to market authorization surveillance and the set-up of a pharmacovigilance system.
Our services include:
Set up of Pharmacovigilance system
- Validated Safety database
- Electronic reporting to EudraVigilance (Certified user)
- Safety/Pharmacovigilance consultation
Coding of medical terms/adverse events (MedDRA) and medications (WHO-DDE)
Clinical studies
- SAE handling, incl. assessment and narrative writing
- Development Safety Update Report (DSUR) writing
- Risk-Management Plan
- Safety Review
Post-marketing pharmacovigilance
- Case report handling, including assessment and narrative writing
- Literature Searches
- Periodic Safety Update Report (PSUR) writing
- Signal detection
- Pharmacovigilance System Master File (PSMF)
- Qualified Person Responsible for Pharmacovigilance (QPPV)
TFS has Pharmacovigilance/Drug Safety teams based in the US and Europe.
