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:
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.
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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