Faced with a PRAC-EMA audit requiring identification of missed pregnancy cases across 91 products within 30 days, a client used IQVIA’s Vigilance Detect. The platform reviewed 855K+ cases with 100% accuracy, cutting manual effort by 96%. Nine percent of records were identified as true pregnancy exposures, and all regulatory deadlines were met with zero missed cases. Automated detection paired with pharmacovigilance specialist validation ensured compliance, eliminated false negatives, and significantly reduced resource strain, showcasing the efficiency of AI-enabled pharmacovigilance.

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