PV case processing, PSUR/DSUR, signal detection.
Case intake, MedDRA coding, narrative writing (with TraceDraft), aggregate reporting and signal detection — as a service or as a technology deployment.
Pharmacovigilance covers the detection, assessment, understanding and prevention of adverse effects — case processing, signal detection, aggregate reporting and risk management, under GVP in the EU and equivalent expectations elsewhere. The operational pressure is case volume against regulatory reporting clocks that do not move.
Outcomes you can expect
- Compliant case processing
- Aggregate reports delivered
- Signal detection cadence
Pharmacovigilance is delivered by our regulatory services practice. Where it saves time, the team uses our products: GxP Copilot for validation lifecycle work and TraceDraft for clinical documentation.
Explore related capabilities: Regulatory Compliance, Regulatory Intelligence, Regulatory Information Management (RIM), eQMS Implementation & Validation.
ICSR Processing: The Core PV Compliance Obligation
Individual Case Safety Report (ICSR) processing is the primary pharmacovigilance compliance obligation for marketing authorisation holders. GVP Module VI specifies the obligations: solicited and spontaneous ICSRs must be processed within defined timelines (7 days for fatal or life-threatening ICSRs in clinical trials, 15 days for all other serious unexpected suspected adverse reactions, 90 days for non-serious cases); each ICSR must be MedDRA-coded, causality-assessed, and narrative-written; and expedited reports must be submitted to the relevant regulatory authority within the applicable deadline.
ICSR processing compliance requires a functioning case intake system (receiving reports from multiple sources — sites, literature, social media, post-market surveillance, product complaints), a coded and documented narrative for each case, and a submission infrastructure that transmits expedited reports in E2B format within the regulatory deadline. Missing a single 7-day or 15-day deadline is a GVP Module VI finding; systematic deadline non-compliance is a warning letter or authority action risk. Our PV case processing service provides end-to-end ICSR management with a defined SLA for each case type.
- 1Adverse event listing · row 14
- 2Lab dataset · ALT value, day 15
- 3Protocol · section 7.2
Aggregate Reporting: PSUR, DSUR, PBRER
Aggregate safety reports — the Periodic Safety Update Report (PSUR), the Development Safety Update Report (DSUR), and the Periodic Benefit-Risk Evaluation Report (PBRER) — compile the cumulative safety experience with a product over a defined period and assess the current benefit-risk profile. These are among the most complex clinical documents produced for a product: they require aggregation of all ICSR data from all sources over the reporting period, identification of emerging signals against the reference safety information, benefit-risk assessment in the current therapeutic context, and presentation in the defined ICH E2C format.
TraceDraft's aggregate report module ingests the ICSR database export for the reporting period, aggregates exposure-adjusted incidence rates for MedDRA-grouped AE categories, identifies changes from the prior reporting period, and generates a structured first draft aligned to ICH E2C PBRER format. The medical writer and pharmacovigilance physician then focus on the clinical interpretation — signal assessment, benefit-risk narrative, reference safety information update recommendations — rather than on data aggregation and table construction. For organisations with annual PSUR obligations to EMA and quarterly DSUR obligations to FDA during development, this approach substantially reduces the writing cycle time for each aggregate report.
Signal Detection and Safety Monitoring
Signal detection is the process by which a potential new safety concern — an unexpected association between a product and an adverse event — is identified in the cumulative ICSR database. ICH E2C and GVP Module IX define the signal detection methodology: at minimum, a defined quantitative disproportionality analysis method (reporting odds ratio or proportional reporting ratio) applied to the ICSR database at a defined frequency, with a defined threshold for signal identification and a defined clinical review process for each identified signal.
Our signal detection service provides the full detection-to-assessment cycle: quantitative disproportionality analysis run monthly against the ICSR database; clinical review of all signals above the detection threshold by a qualified pharmacovigilance physician; signal assessment documentation including the cumulative case series review, published literature search, and benefit-risk context assessment; and communication of assessed signals to the regulatory affairs team for decision on whether label update, communication to investigators, or regulatory notification is required. Signal detection records are maintained in the pharmacovigilance database as auditable documentation of the organisation's ongoing safety monitoring process.
Sources
Primary documents referred to on this page, from their official publishers.
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