Intake
Safety information is received, logged and checked for validity.
Collection, assessment, MedDRA coding and electronic submission of Individual Case Safety Reports.
Individual Case Safety Reports (ICSRs) describe suspected adverse reactions to a medicinal product. Their collection, validation, follow-up and reporting within regulatory timelines are core pharmacovigilance obligations, described in GVP Module VI.
URAS PV manages the full case lifecycle and submits ICSRs electronically to systems such as EudraVigilance and FDA FAERS, using the ICH E2B format.
Safety information is received, logged and checked for validity.
Cases are coded in MedDRA, assessed and completed with follow-up information.
Reports are submitted electronically to the relevant authorities on time.
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 detailsProactive signal detection, benefit-risk analysis, and the preparation of periodic safety reports (PBRER / DSUR).
Signal management 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.
Request a Free Assessment