Detection
Safety data are reviewed regularly to identify potential signals.
Proactive signal detection, benefit-risk analysis and periodic safety reports (PBRER / DSUR).
Signal management is the process of detecting, validating, analysing and acting on new information about the risks of a medicinal product, as described in GVP Module IX. It feeds directly into the benefit-risk evaluation of every product.
URAS PV performs regular signal detection, documents each step, and prepares periodic safety reports such as PBRERs (ICH E2C(R2)) and DSURs (ICH E2F).
Safety data are reviewed regularly to identify potential signals.
Signals are validated, analysed and their impact on the benefit-risk balance assessed.
Outcomes are documented and communicated, including updates to product information when needed.
We build global PV systems fully compliant with international standards (ICH, GVP) and act as local LPPV representatives in 15+ countries.
Global and local pharmacovigilance detailsWe assume marketing authorisation holders' legal obligations with our EU QPPV, UK QPPV, and country-based qualified person (LPPV) services.
QPPV outsourcing detailsFull-scope support for creating, maintaining, and keeping the Pharmacovigilance System Master File (PSMF) inspection-ready at all times.
PSMF writing and management detailsWriting and review of pharmacovigilance SOPs and working instructions aligned with GVP and local requirements.
SOP writing detailsCollection, assessment, coding (MedDRA), and electronic submission of Individual Case Safety Reports (ICSR) to systems such as EudraVigilance and FDA FAERS.
ICSR processing detailsContinuous monitoring of global and local literature (PubMed + local journals), case identification, and reporting.
Literature monitoring detailsOur validated safety database unifies ICSR management, coding, and regulatory submissions on a single platform.
Safety database detailsPV audit preparation, internal audit services, and regulatory training programmes for your teams.
Audit and training detailsAn overview of our end-to-end pharmacovigilance services.
All pharmacovigilance servicesTalk to our team and let us design a tailored solution for you.
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