Servicesmedfiles pharmacovigilance services

Human Medicinal Products – Post-Marketing Services

  • Processing of adverse reaction reports
  • Registration of product information in Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Electronic reporting of adverse reactions to EudraVigilance
  • MedDRA coding
  • Support in reconciliation processes
  • Translations of adverse reaction reports and other pharmacovigilance documentation
  • Acting as contact person with local authorities
  • Monitoring of local and global medical literature
  • Writing, submission and review of periodic safety update reports (PSURs)
  • Writing and review of standard operating procedures (SOPs) and working instructions / user manuals
  • Writing and maintenance of Pharmacovigilance system master file (PSMF)
  • Support in signal management process
  • Risk management / risk minimisation activities
  • EU Qualified Person for Pharmacovigilance (QPPV) services

Veterinary Medicinal Products – Post-Marketing Services

  • Processing of adverse reaction reports
  • Registration of product information in Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Electronic reporting of serious adverse reactions to EudraVigilance
  • VedDRA coding
  • Support in reconciliation processes
  • Translations of adverse reaction reports and other pharmacovigilance documentation
  • Acting as contact person with local authorities
  • Monitoring of local and global medical literature
  • Writing, submission and review of periodic safety update reports (PSURs)
  • Writing and review of standard operating procedures (SOPs) and working instructions / user manuals
  • Writing and maintenance of detailed description of pharmacovigilance system (DDPS)
  • Support in signal management process
  • Risk management / risk minimisation activities

Clinical Trials

  • Support in planning of clinical trials
  • Processing of adverse event reports: triage, data entry, MedDRA coding, assessment, medical review, determination of reportability
  • Registration of product information in Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Electronic reporting of SUSARS in EudraVigilance
  • Support in reconciliation processes
  • Translations of adverse event reports and other pharmacovigilance documentation
  • Writing, submission and review of development safety update reports (DSUR)
  • Writing and review working instructions / user manuals

Medical Device Incidents and Recalls

  • Incident reporting to authorities
  • Reports on field safety corrective actions related to recalls
  • Reports on field safety corrective actions related to device modifications
  • Writing of field safety notices

Pharmacovigilance Agreements (PVA)

  • Assistance in writing PVAs
  • Provision of PVA templates

PV Audits, Quality Assurance, PV Training and Consultation
QP, quality and distribution