Pharmacovigilance services

Our pharmacovigilance team consists of highly dedicated professionals with experience both from the pharmaceutical industry and the CRO business. Our processes are fully compliant with local and international regulations and guidelines. Our team is specialized in drug/patient safety and pharmacovigilance services to pharmaceutical and biotechnology companies of all sizes.

Services

  • Adverse event management
    • • Support in planning of clinical trials
    • • Processing of reports: triage, data entry, MedDRA/VedDRA coding,
      assessment, medical review, determination of reportability
    • • Electronic transmission of expedited safety reports
    • • Follow-up
    • • Support in reconciliation processes
       
  • Registration of product information in Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Translation of adverse event reports and other pharmacovigilance documentation
  • Acting as the contact person with local authorities
  • Monitoring of local and global literature
  • Writing, submission and review of periodic safety update reports (PSURs)
    and development safety update reports (DSUR)
  • Writing and review of standard operating procedures (SOPs) and working instructions / user manuals
  • Pharmacovigilance system master file (PSMF)
    • • Writing and maintenance of PSMF
    • • Transfer of detailed description of pharmacovigilance system (DDPS) to PSMF
  • DDPS for veterinary products
  • Support in signal management process
  • Risk management / risk minimization activities
    • • Operative risk management tasks
    • • Writing and maintenance of risk management plans (RMP)
  • EU Qualified Person for Pharmacovigilance (QPPV) services
    • • EU Qualified Person for Pharmacovigilance (QPPV)
    • • EU deputy QPPV
    • • 24/7 service readiness
    • • Supporting client’s QPPV in his/her role, e.g. carrying out compliance
      and quality tasks for pharmacovigilance
    • • Set-up and maintenance of pharmacovigilance systems and related quality systems
  • Pharmacovigilance agreements (PVA)
    • • Assistance in writing PVAs
    • • Provision of PVA templates
  • 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

For more information please contact

Director, Healthcare Services Satu Kujala