Reinventing Drug Safety: How End-to-End Pharmacovigilance Automation Cut Manual Effort by 60% and Accelerated Global ICSR/SUSAR Reporting
Client
A global biopharmaceutical company responsible for managing safety reporting across multiple products and regulatory regions, including high-volume ICSR and SUSAR submissions.
Business Need
The client’s Pharmacovigilance (PV) operations were heavily dependent on manual case processing, requiring significant effort for case intake, narrative writing, medical assessment, and E2B submissions. With increasing caseload volume and tightening regulatory timelines, manual workflows led to backlogs, rework, and delayed submissions. Ensuring global regulatory compliance—including real-time validation, audit trails, and traceability—added further pressure. The client needed a scalable automation solution to reduce workload, ensure accuracy, and accelerate global safety reporting without compromising quality.
Solution
The organization partnered with Mushroom Solutions to deploy End-to-End Pharmacovigilance Automation through the Mushroom PV platform. The solution digitized the entire ICSR lifecycle—from case intake across multiple sources (call centers, emails, literature, and safety databases) to automated narrative generation and E2B(R2/R3) submissions.
AI- and rules-based engines extracted data from source documents, populated standard safety fields, and generated context-rich safety narratives aligned with regional regulatory guidelines. Real-time validation checkpoints and audit trails ensured accuracy, consistency, and compliance before submissions. The automated system also enabled seamless gateway submissions to global health authorities, eliminating manual handoffs and repetitive data entry. ross departments
Benefits
- 60% reduction in manual workload for safety teams through automation of intake, documentation, and submissions.
- Faster ICSR/SUSAR reporting, dramatically reducing turnaround time for regulatory submissions.
- Improved accuracy and compliance with real-time validation and automated audit trails.
- Minimized rework and delays, ensuring safety cases were complete and submission-ready on first pass.
- Scalable PV operations, equipped to handle increasing case volumes without additional staffing.