Pharmacovigilance and Drug Safety

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.