
Pharmacovigilance teams still intake adverse events, code them to MedDRA, and read free text narratives for safety signals largely by hand. A signal buried in an unstructured report can take as long to find as the report took to write.
AI reads at the volume the mandate requires. Document AI extracts adverse events from intake forms and free text narratives. Predictive models code to MedDRA with a confidence score attached, and flag the signal a narrative is carrying before a person searches for it. Generative AI drafts the regulatory submission a reviewer signs off on. A medical reviewer still signs every case, running on infrastructure you control.