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.

  

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