Pharmacovigilance

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function.

Pharmafile PV Services offer a range of services including the following:

  • Eudravigilance Registration.

  • Pre-submission development for new application (including Generics) Risk Management Planning (RMP) and Consultancy.

  • Development of a new PSMF, or peer review of your PSMF.

  • Maintenance of your PSMF.

  • Safety processes and SOPs.

  • Weekly and bespoke literature searching using PUBMED, EMBASE, MEDLINE and other databases as required.

  • Review of literature to identify individual case safety reports (ICSRs) for inclusion in the PSUR.

  • Case narratives.

  • Medical review.

  • Signal detection and evaluation, and issue workups.

  • Benefit-Risk review and re-assessment.

  • Risk Evaluation Mitigation Strategy (REMS).

  • Clinical Expert Statements.

  • QPPV and Deputy QPPV services for clients entering or currently working in the EU Zone.

  • Safety Data Exchange Agreements (SDEA) and Consultancy.

  • Periodic Safety Update Reports (PSURs) / Periodic Benefit Risk Evaluation Reports (PBRERs) and related activities including PSUR harmonisation and legacy PSURs.

  • Addendum to the clinical overview.

  • Assistance with responses to Competent Authorities.

  • Pre- and post-inspection support, including:

  • Audit and inspection preparation.

  • Objective review of current systems, processes and documentation to identify weaknesses or gaps.

  • Implementation of corrective and preventative actions.

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For more information please contact us at enquiries@pharmafile.ie