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AI Transforms Pharmacovigilance Into Predictive Safety
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6.1
Vikalp Khare, Director and Head of US GPV Safety Data Management, describes how AI and cloud automation are reshaping pharmacovigilance operations today. He outlines NLP-driven ICSR extraction, machine-learning signal detection across rising case volumes (FDA ICSRs rose from ~700,000 in 2010 to over 2.1 million today), and urges cloud integration, governance, and workforce upskilling to maintain compliance and patient safety.
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Strong industry relevance and actionable guidance, offset by limited novelty and opinion-based, single-source perspective reducing empirical evidence.
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