Pharmacovigilance services

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

Services

  • Human medicinal products - post-marketing services
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    • • 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
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  • Veterinary medicinal products - post-marketing services
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    • ‚Äč• 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
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  • Clinical trials
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    • • 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
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  • Medical device incidents and recalls
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    • • 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
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  • Pharmacovigilance agreements (PVA)
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    • • Assistance in writing PVAs
    • • Provision of PVA templates
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  • PV audits, quality assurance, PV training and consultation
    › QP, quality and distribution

For more information please contact

Director, Clinical Research Satu Kujala