The Real Cost of Manual Case Intake Operations – and What GenAI Changes

 Pharmacovigilance exists to protect patients. Case intake exists to make that possible. Yet in most organizations, the intake process routes the majority of its time and resources through work that has nothing to do with safety assessment – transcribing calls, extracting data from PDFs, populating case fields line by line, and chasing missing information. The people best positioned to evaluate drug safety are spending their day doing data entry. That is not a staffing problem. It is a process design problem.



The core reason behind this challenge is that manual case intake is treated as a fixed operational reality by most PV teams, not as a cost with a measurable price tag. This persistent but hidden cost shows up in processing timelines, data quality failures, submission delays, follow-up gaps, and the disproportionate share of skilled reviewer time that goes toward data entry rather than medical judgment.

GenAI is changing the economics of that upstream work, not by replacing human reviewers, but by changing what they spend their time on.

The Structural Case Against Manual Intake

A study published in Clinical Pharmacology and Therapeutics found that case processing activities consume up to two-thirds of internal pharmacovigilance resources based on PVNet benchmark data. When outsourcing costs are added, case processing spending accounts – on average – for the majority of a pharmaceutical company’s total PV budget.

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