Search Strategy
Search terms are defined for each active substance and source.
Continuous monitoring of global and local literature, case identification and reporting.
Marketing authorisation holders are expected to screen the worldwide scientific literature, and in many markets local journals as well, for reports of suspected adverse reactions and other safety information, as described in GVP Module VI.
URAS PV combines global database searches such as PubMed with monitoring of local journals, identifies valid cases and relevant safety information, and passes them into the ICSR and signal management processes.
Search terms are defined for each active substance and source.
Articles are screened for cases and relevant safety information.
Valid cases go to ICSR processing, other findings to signal management.
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 detailsProactive signal detection, benefit-risk analysis, and the preparation of periodic safety reports (PBRER / DSUR).
Signal management 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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