Automation in Case Processing: How AI is Changing Drug Safety

In the ever-evolving landscape of healthcare and pharmaceuticals, drug safety—or pharmacovigilance—remains a top priority. Monitoring and managing adverse drug reactions (ADRs) is essential to protecting patient health and ensuring regulatory compliance. However, as global reporting requirements increase and the volume of safety data skyrockets, traditional manual methods for processing adverse event cases are becoming unsustainable.

Enter automation and artificial intelligence (AI)—technologies that are revolutionizing case processing and redefining the future of pharmacovigilance.

This blog explores how automation and AI are transforming case processing in drug safety, reducing manual burden, improving accuracy, and enabling faster, smarter decision-making.

What Is Case Processing in Drug Safety?

Case processing refers to the end-to-end workflow involved in handling individual case safety reports (ICSRs), which are records of suspected adverse reactions to medications. These cases come from multiple sources—healthcare providers, patients, regulatory bodies, clinical trials, literature, and even social media.

The typical case processing workflow includes:

• Case intake – receiving and capturing source documents.

• Data entry – extracting and entering key details (e.g., patient info, drug name, adverse event) into safety databases.

• Data coding – standardizing terms using dictionaries like MedDRA and WHO-DD.

• Case assessment – determining seriousness, expectedness, and causality.

• Quality control – verifying the accuracy and completeness of data.

• Regulatory submission – sending the case to the appropriate authority within mandated timelines.

  
  

Each of these steps is vital—but traditionally time-consuming and prone to human error.The Future of Case Processing

The future of pharmacovigilance is increasingly intelligent and proactive. As AI systems evolve, we can expect:

• End-to-end automation of ICSR processing from intake to submission.

• Predictive signal detection based on real-time safety data.

• Multilingual AI models capable of processing global cases.

• Voice-to-text case intake from call center ADR reports.

• Self-learning agents that continuously optimize workflows.

AI is not just changing how we process cases—it’s reshaping how we ensure drug safety.

Benefits of AI-Powered Case Processing

• Faster Turnaround

Automated systems can process cases in minutes, compared to hours of manual work. This helps meet tight regulatory timelines (e.g., 15 calendar days for serious, unexpected ADRs).

• Improved Accuracy

AI ensures consistent data capture, coding, and classification—reducing human interpretation errors and variability.

• Scalability

AI can handle surges in case volume without proportional increases in staffing. This is especially beneficial during clinical trials, drug launches, or public health emergencies.

• Cost Savings

With automation, fewer resources are needed for repetitive tasks. Human experts can be reassigned to higher-value work like signal detection, risk assessment, and safety strategy.

• Regulatory Compliance

AI tools can be configured to enforce business rules, completeness checks, and submission deadlines—reducing the risk of non-compliance.

Conclusion

Automation and AI are fundamentally transforming case processing in drug safety. By taking over routine tasks, these technologies free up pharmacovigilance professionals to focus on strategic insights and proactive risk management. Faster, more accurate, and scalable case handling is no longer a future vision—it’s happening now.

See how we can transform your drug safety operations. Schedule a demo!

For pharmaceutical companies, embracing AI in pharmacovigilance is not just about efficiency—it’s about staying compliant, ensuring patient safety, and preparing for the data-driven future of healthcare.