PvEdge

Sarjen’s PvEdge is a comprehensive, business- and GxP-compliant pharmacovigilance software solution built to support safety surveillance for drugs, vaccines, medical devices, combination products, and both human and veterinary healthcare. It centralizes intake of safety data from multiple sources—medical information call centers, literature, regulatory reports, web input—into a unified inbox, enabling efficient triage, case tracking, and processing. The platform automates many critical functions: updating MedDRA terms, generating patient narratives, running quality control checklists, validating XML outputs, and managing labeling & casualty matrices. PvEdge supports regulatory-report submissions in formats such as R2 XML, R3 XML, CIOMS, MedWatch, VAERS, among others, and integrates with global regulatory requirements (FDA, EMA, MHRA, PMDA, TGA, KFDA etc.). It also includes modules for document & training management, safety data exchange, automated periodic safety reports (PSUR, PADER, TDC), risk management planning, and signal detection using algorithms like Proportional Reporting Ratio and Chi-square. Designed for scalability and compliance, features such as multivigilance, multi-tenant architecture, cloud readiness, pre-validation, AI-enabled automation and rapid implementation ensure a strong return on investment. PvEdge streamlines operations, increases accuracy, ensures regulatory compliance throughout the safety lifecycle, and helps organizations focus on innovation by reducing manual effort and improving safety data quality.