Pharmacovigilance

TMC's pharmacovigilance and medical professionals work together to provide a comprehensive suite of pre- and post-marketing pharmacovigilance services

TMC has a fully compliant and validated safety database, which can be partitioned to allow secure client access to their trials or products and can be configured for worldwide case reporting requirements.

TMC has an EU Qualified Person for Pharmacovigilance and local pharmacovigilance representatives in the territories that require them and can therefore ensure local country compliance as part of a global service.

The specialist PV team covers the activities detailed below:

Pre-approval services

  • Provision of Responsible Person for EudraVigilance
  • EudraVigilance and XEVMD registration and maintenance
  • Medical review and assessment of serious adverse events
  • SUSAR reporting to EudraVigilance and Competent Authorities
  • Ongoing medical safety surveillance and benefit-risk evaluation
  • Preperation and submission of Development Safety Update Reports (DSURs)

Peri- and post-approval services

  • Preparation and maintenance of the PV System Master File (PSMF)
  • Provision of EU Qualified Person for Pharmacovigilance (QPPV) for authorised products
  • Provision of local QPPVs in territories that require them
  • Planning and conduct of PV Audits
  • EudraVigilance and XEVMD registration and maintenance
  • Literature surveillance
  • ICSR reporting to EudraVigilance and Competent Authorities
  • Preperation and submission of Periodic Safety Update reports (PSURs / PBRERs)
  • Ongoing Signal Management and benefit-risk evaluation