PV Agentic LLM – AI for Pharmacovigilance Automation

Solution Overview

Pharmacovigilance Agentic LLM is an AI-powered solution designed to revolutionize pharmacovigilance by automating adverse event intake, processing, and analysis. It leverages large language models (LLMs) to handle unstructured safety data, enhance signal detection, and improve compliance with regulatory requirements.More

Pharmacovigilance Agentic LLM is an AI-powered solution designed to revolutionize pharmacovigilance by automating adverse event intake, processing, and analysis. It leverages large language models (LLMs) to handle unstructured safety data, enhance signal detection, and improve compliance with regulatory requirements. By streamlining case intake and reducing manual effort, Pharmacovigilance Agentic LLM accelerates decision-making, minimizes compliance risks, and ensures a proactive approach to drug safety while lowering costs and operational burdens for pharmaceutical companies.

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Industry Challenge

Pharmacovigilance teams face increasing workloads due to the rising volume of adverse event reports from multiple sources. Manual case processing is slow, costly, and prone to errors, increasing regulatory compliance risks. Companies struggle with scaling operations while maintaining accuracy and meeting stringent timelines. There is a pressing need for automation-driven solutions that enhance efficiency, ensure compliance, and improve patient safety outcomes by leveraging AI and natural language processing (NLP).

Solution Highlights

AI-Powered Case Processing

Automates adverse event intake, classification, and report generation using LLMs

Regulatory Compliance Automation

Ensures adherence to global pharmacovigilance regulations with automated case triage and validation

Advanced Signal Detection

Identifies safety signals faster by analyzing unstructured safety data sources

Scalable Workflows

Adapts to increasing case volumes with AI-driven workflow automation

Enhanced Data Extraction

Extracts key safety information from structured and unstructured reports with high accuracy

Solution Benefits

  • Automates data capture, thereby reducing manual effort by 60%
  • 45% effectiveness in case prioritization & responsiveness
  • Enhancing signal detection accuracy by 20%
  • Reducing operational costs by more than 50%

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