A manufacturer-aware cross-system benchmark for pediatric pharmacovigilance signal concordance.

Introduction: Pediatric adverse drug reactions are difficult to evaluate after approval because pediatric trial evidence is limited and spontaneous-report systems differ in product naming, event coding, seriousness fields, and duplicate submissions. Methods: We developed a manufacturer-aware benchmark for pediatric pharmacovigilance signal concordance using the FDA Adverse Event Reporting System (FAERS)/AERS as the source system, Canada Vigilance as a cross-system reporting-signal comparator, and JADER for descriptive third-country context. Active ingredients and five clinically adjudicated serious endpoint families were harmonized before detectable manufacturer cross-filing was screened. Results: The supervised benchmark contained 628 drug-endpoint-period rows: 147 manufacturer-screened Canada Vigilance reporting-signal positives and 481 Canada Vigilance co-report-absent comparators. An endpoint-conditioned FAERS co-reporting comparator achieved an area under the precision-recall curve (AUPRC) of 0.753. Elastic-net logistic regression reached 0.767, and a LightGBM comparator reached 0.774, but clustered paired-difference intervals Discussion: Clinical label specificity, detectable duplicate screening, and fair source-signal comparators materially influenced model evaluation. The resulting resource provides a reproducible reference for pediatric signal triage and for testing whether new pharmacological features or models add information beyond established reporting statistics.