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🛡️ Post-Market Safety AI

AI Pharmacovigilance & Complaints Manager

Advanced AI system that handles adverse event reporting and product complaints using LLMs to process adverse event narratives, sentiment analysis on market feedback, and signal detection in complaint trends.

Pharmacovigilance AI

Advanced Safety Monitoring

🧠 AI Implementation Across Pharmacovigilance Duties

Comprehensive AI automation for all aspects of pharmacovigilance operations, from signal detection to regulatory compliance

1. SOP Development & Compliance

AI Solution:

  • • LLM-based document generators (OpenAI, Claude, AWS Bedrock) for auto-drafting SOPs
  • • NLP-based SOP reviewers for consistency and compliance
  • • Auto-flag outdated clauses using regulatory guidelines
2. Signal Management

AI Solution:

  • • ML models for signal detection (disproportionality analysis, Bayesian neural networks)
  • • NLP models for extracting safety signals from case narratives
  • • PubMed mining for literature-based signal detection
3. Aggregate Safety Reports (PADER, PSUR, PBRER)

AI Solution:

  • • Automate report generation using template-filling AI
  • • LLM for narrative writing (benefit-risk discussions)
  • • AI for compliance checks and formatting validation
4. Oversight & Monthly Compliance

AI Solution:

  • • RPA bots (UiPath) to monitor case volume and overdue tasks
  • • Compliance dashboard with AI alerts for threshold breaches
  • • Automated audit readiness monitoring
5. ICSR Management

AI Solution:

  • • Automate case triage and seriousness assessment
  • • NLP for MedDRA auto-coding and narrative summarization
  • • Integration with Oracle Argus + LLM plugin
6. Scientific Documentation

AI Solution:

  • • GPT-4 + domain-tuned model for enhanced case documentation
  • • Automate literature case intake using AI bots
  • • PDF NLP extractors (Glean, Adobe AI, Amazon Textract)
7. PV Training

AI Solution:

  • • AI-powered PV chatbot tutor for new hires
  • • Real-time SOP Q&A assistance
  • • Adaptive learning platforms (Docebo AI, LearnUpon + LLM)
8. Regulatory Communication

AI Solution:

  • • Email response generators for inspection readiness
  • • AI-powered summarizers for authority correspondence
  • • RegAsk AI for regulatory update scanning
9. SDEA & RMP

AI Solution:

  • • Contract AI (Kira, Luminance) to extract SDEA clauses
  • • AI-enabled RMP drafting assistants
  • • Update RMP sections per latest safety findings
10. XEVMPD & SPOR

AI Solution:

  • • Structured data parsers + AI validation for Article 57 compliance
  • • SPOR-AI agents for auto-suggesting missing entries
  • • Wrong mapping detection during database updates

Key Benefits & ROI

Transform your pharmacovigilance operations with measurable improvements in efficiency, compliance, and cost reduction

85%

Faster Case Processing

Automated ICSR triage and MedDRA coding reduces processing time

99.5%

Compliance Accuracy

AI-driven compliance checks ensure regulatory adherence

70%

Improved Signal Detection

Advanced ML algorithms identify safety signals earlier

60%

Cost Reduction

Automated workflows reduce manual effort and operational costs

Technical Specifications

Enterprise-grade AI infrastructure designed for pharmaceutical compliance and scalability

AI Technologies & Tools

Large Language Models

OpenAI GPT-4ClaudeAWS Bedrock

Machine Learning

Bayesian Neural NetworksDisproportionality AnalysisNLP Models

Automation Tools

UiPath RPAAmazon TextractAdobe AI
Integration & Compliance

Safety Databases

Oracle ArgusVeeva VaultXEVMPD

Regulatory Standards

ICH E2B(R3)FDA CFR 21EU SPORMedDRA

Security & Validation

21 CFR Part 11GDPR CompliantCSV Validated

Ready to Transform Your Pharmacovigilance Operations?

Deploy our AI Pharmacovigilance & Complaints Manager to automate safety monitoring, ensure regulatory compliance, and accelerate signal detection.

Hire This AI-EmployeeSchedule Consultation