The Challenge
A global pharma company managing a growing product portfolio in Europe was overwhelmed by the volume and complexity of adverse event (AE) reports pouring in from multiple markets. Their pharmacovigilance team was manually reviewing thousands of individual case safety reports (ICSRs) and periodic safety update reports (PSURs) to detect safety signals.
Major pain points included:
- Lagging signal identification due to manual triage and reviews
- High resource costs associated with manual case assessments
- Risk of missed emerging safety patterns across datasets
- Delayed updates to Risk Management Plans (RMPs) and label changes
- Limited real-time insight into cumulative AE trends by product
Our Solution
Agile Genix deployed a machine learning–based signal detection system, custom-tuned for pharmacovigilance workflows and aligned with EudraVigilance data handling standards.
✅ ML-Powered Signal Detection Models
Developed supervised and unsupervised models to detect unusual frequency patterns in adverse events, stratified by geography, patient type, and product.
✅ Case Prioritization Engine
Used NLP techniques to extract critical info from narrative fields, allowing the system to score and rank cases by severity and novelty.
✅ Integration with Safety Database
Built secure APIs to ingest ICSRs from the client’s Argus Safety system and output high-priority flags for medical review teams.
✅ Interactive Safety Dashboards
Enabled pharmacovigilance officers to visualize trends, cluster emerging signals, and drill into product-specific AE clusters — using Power BI and R Shiny.
✅ Regulatory Alignment
Validated models to ensure explainability and compliance with EMA GVP Module IX, ICH E2E, and MHRA guidance on signal management.
Impact Delivered
- Reduced signal detection turnaround time by 70%
- Increased early warning detection by 2.3x compared to manual review
- Automated case triage freed up 30% of PV staff time
- Strengthened readiness for regulatory safety inspections
- Enabled proactive label updates and faster safety communication cycles
Looking to Bring AI into Your PV Operations?
Don’t wait for a signal to be missed. Let Agile Genix help you integrate AI into your pharmacovigilance workflows — safely, intelligently, and compliantly.
Schedule a Pharmacovigilance AI Consultation
Talk to us about AI models that can cut costs and improve safety outcomes.