The Challenge
A leading pharmaceutical company managing post-marketing drug safety reports had growing concerns around data leaks and insider risk. Their pharmacovigilance system — integrated with global health authority portals and third-party vendors — was handling thousands of adverse event (AE) cases monthly.
Issues included:
- Inconsistent user access control across PV systems
- Unmonitored vendor and contractor access to safety data
- Manual audit trail logging, prone to manipulation or gaps
- Lack of automated alerts on suspicious access patterns
- Increased compliance risk with FDA and EMA safety inspections on the horizon
Our Solution
Agile Genix designed and implemented a layered security program tailored for pharmacovigilance systems and regulatory environments.
✅ Risk Assessment & Threat Modeling
Conducted internal threat simulation to identify blind spots in user roles, shared credentials, and data access behavior.
✅ Role-Based Access Redesign
Restructured the entire PV system’s IAM policies — introducing granular role definitions, time-based access, and regional access filters.
✅ User Behavior Monitoring (UBM)
Deployed machine learning–based monitoring tools to detect anomalies such as unusual download times, location changes, or access to non-assigned AE records.
✅ Automated Logging & Immutable Trails
Integrated AWS CloudTrail and Splunk to ensure tamper-proof, centralized activity logs aligned with 21 CFR Part 11.
✅ Incident Response Playbooks
Developed internal SOPs, alert thresholds, and automated escalation workflows for the compliance and IT security teams.
Impact Delivered
- Detected and prevented 2 active insider threat attempts within 60 days
- Achieved 100% visibility across user and vendor access logs
- Enabled regulatory audit compliance with clean trail history
- Reduced manual monitoring efforts by 40%
- Elevated pharmacovigilance data protection to meet EMA, MHRA, and FDA inspection standards
Concerned About Internal Data Exposure?
When lives depend on safety data integrity, your systems need to be protected from the inside out. Agile Genix specializes in securing regulated workflows across pharmacovigilance and clinical domains.
Book a Threat Risk Evaluation
Let’s assess your exposure and strengthen your internal controls.