Use Case: Post-Market Surveillance and Safety Powered by AI

The work doesn’t stop when a drug reaches the market. In fact, one of the most critical phases begins: monitoring patient safety. Pharmacovigilance is a regulatory requirement and a vital safeguard for public health. But managing it is complex and time-sensitive. AI agents are making it easier. 

The Challenge 

Post-market surveillance means collecting and analyzing signals from multiple sources: emails, reports, call center logs, even news articles. These signals often arrive in unstructured formats, making them difficult to process quickly. Manual workflows slow response times, increase risk, and put compliance at stake. When safety issues arise, every minute matters. Delays can lead to regulatory penalties, reputational damage, and most importantly, patient harm. 

The Turning Point 

AI agents bring speed and structure to this critical process. Instead of relying on manual data entry and fragmented systems, intelligent agents can capture unstructured information, extract relevant insights, and organize it for compliance workflows. They can even draft initial responses for review, so teams act faster without sacrificing control. 

Example: Cegeka’s Quality Impact Recall Agent 

Pharmacovigilance often overlaps with quality management. When a product defect or adverse reaction is detected, companies must act immediately to protect patients and comply with regulations. Cegeka’s Quality Impact Recall Agent shows how AI can transform this process. 

Integrated with Microsoft Dynamics 365 Finance & Supply Chain Management and powered by Copilot Studio, this agent: 

• Monitors quality deviations continuously across production and distribution. 
• Analyzes downstream impact to identify affected batches and customers. 
• Drafts tailored notifications for recalls or safety alerts, aligned with company policies. 
• Works within ERP logic to ensure compliance and traceability. 

Instead of hours of manual coordination, the agent delivers clarity and control in minutes. Your team stays in charge, reviewing and approving actions, while the agent handles the complexity behind the scenes. 

Start Small 

Building a full pharmacovigilance automation system doesn’t happen overnight. The best approach is to start with one targeted use case, like recall orchestration. Validate its performance, learn from it and expand it to broader workflows such as signal detection, case management, and regulatory reporting. This incremental strategy reduces risk, builds confidence, and creates a foundation for long-term transformation. 

Ready to explore what your first AI agent could look like? Let’s talk about the small steps that lead to big change. 

Want more Inspiration? Explore other AI use case in Pharma: 
- Smarter Manufacturing and Quality Control with AI 
- Accelerating Pharma Research with AI Agents  
- Clinical Trials Reimagined with AI Agents  

Source: UiPath