PVLR — Pharmacovigilance Literature Review Radar
Automated weekly literature monitoring across 30+ journals and databases. GVP Module VI compliant. Built to turn a manual, resource-intensive regulatory obligation into a documented, auditable process.
Literature monitoring is a regulatory obligation. Most companies do it badly.
GVP Module VI (Appendix 2) requires marketing authorisation holders to conduct systematic medical literature monitoring — at minimum weekly — across globally indexed databases and locally relevant journals. Any publication that contains a suspected adverse reaction for a registered product is a potential ICSR. If it meets the four minimum criteria, it must be reported to the authority within the applicable timeframe.
In practice, literature monitoring is often conducted manually: a team member running ad-hoc searches, downloading PDFs, making judgment calls without documented criteria, and producing no auditable evidence of the process. When an EDA inspector asks for literature monitoring records, this approach fails immediately.
PVLR was built to solve this precisely — for Egyptian and MENA pharma companies operating under EDA, PVGA, and GVP Module VI requirements.
How PVLR works
1. Automated Weekly Search
PVLR runs structured, documented searches across 30+ indexed medical journals and pharmacovigilance databases on a defined weekly schedule. Searches are constructed around active substance names, brand names, and product-specific variants — aligned with GVP Module VI guidance on search construction to maximise recall.
2. Screening & Triage
Retrieved publications are screened against relevance criteria. PVLR flags articles that contain a suspected adverse reaction meeting the minimum ICSR criteria: identifiable patient, identifiable reporter, suspected medicinal product, suspected adverse reaction. Non-relevant results are documented as screened and excluded — with the exclusion reason recorded.
3. ICSR Generation & Audit Trail
Flagged literature cases are passed directly to the PV Radar ICSR workflow for case processing and EDA/PVGA submission. The full search-to-case trail is documented — search date, database, query terms, results retrieved, screening outcome — providing the auditable evidence record that EDA inspectors expect.
Built for GVP Module VI compliance — not just workflow efficiency.
GVP Module VI Appendix 2 is specific about what a compliant literature monitoring process must produce: documented search strategies with defined terms and databases; a defined search frequency (minimum weekly); a documented screening and triage process; and a clear audit trail linking each search to its outcome.
PVLR was built to produce exactly this documentation set — not as a by-product of the software, but as its primary output. The audit trail is not a report you export after an inspection is announced. It is generated automatically with every search cycle, and accessible at any time.
For companies using EMCO Egypt's pharmacovigilance outsourcing service, PVLR is integrated into the operational workflow — literature monitoring is not a separate task managed in parallel but part of the same system that processes ICSRs and maintains the PSMF.
What PVLR covers
30+ Sources
Globally indexed databases including PubMed/MEDLINE, EMBASE, and WHO-PIDM literature channels, plus regionally relevant Arabic-language and MENA pharmaceutical journals not covered by global platforms.
Multi-Product Management
Manage literature monitoring for your entire product portfolio from a single dashboard — each product with its own search strategy, search history, and outcome log. Search strategies are product-specific and reviewed periodically as product data changes.
PV Radar Integration
Literature cases that meet ICSR minimum criteria are passed directly into the PV Radar ICSR workflow. No manual re-entry. The case source is documented as “literature” and the originating publication is attached to the ICSR record.
When the next EDA inspection asks for your literature monitoring records, what will you show them?
PVLR produces the search history, screening records, and ICSR linkage documentation that a compliant literature monitoring programme requires. Book a demo to see how it works for your product portfolio.
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