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Full pharmacovigilance Support

Medwork’s dedicated professionals will ensure full compliance of Marketing Authorization Holders with their regulatory obligations. We provide full pharmacovigilance coverage as well as tailored services that cover specific needs. Our services include:

Full Post-Marketing Pharmacovigilance Support:

  • Establishment of a pharmacovigilance System
  • Undertaking EU QPPV/deputy EU QPPV responsibility
  • Local & global literature review
  • Compilation and maintenance of the PSMF
  • Safety information processing
  • Writing and/or reviewing periodic reports
  • Writing RMPs
  • Interaction with Eudravigilance database including XEVMPD
  • DHPC management
  • Pharmacovigilance personnel back-up
  • Training of pharmacovigilance and non-pharmacovigilance personnel
  • Consulting

Clinical Trials Pharmacovigilance Support:

  • Provision of Responsible Person for pharmacovigilance (RP) for clinical trials
  • Eudravigilance registration
  • Assessment and medical review of serious adverse events
  • SUSAR reporting to Eudravigilance and Competent Authorities
  • Ongoing risk/benefit assessment of the IMP
  • Compilation and update of the DSUR