Pharmacovigilance as a Public-Health Responsibility

Pharmacovigilance is sometimes described as a regulatory compliance exercise — a set of timelines, forms, and submissions that exist to satisfy agency requirements. This framing misunderstands what PV actually is and who it serves. PV is a public health function. Its primary beneficiary is the patient — not the regulator, not the company, not the healthcare professional.

“Pharmacovigilance is a moral contract between science and society — a promise that innovation will not come at the cost of safety.” — Vinay Kumar

When operational pressure conflicts with safety data quality — when throughput targets threaten narrative accuracy, when timeline pressure compromises follow-up — the pharmacovigilance professional has an obligation to escalate. Patient-centricity has moved from aspiration to operational expectation across EMA, FDA, and PvPI’s multilingual reporting channels. In India, where a substantial share of the population uses both conventional and traditional medicines, patient-centred PV requires particular attention to concurrent herbal and ayurvedic use as a source of confounded causality assessments.

This principle has a very concrete, everyday form: it’s the moment a junior associate notices a case doesn’t quite fit the template, or that a narrative reads as thinner than the source documents support, and has to decide whether to flag it even though flagging it will slow the case down. That small decision, repeated thousands of times across an organisation, is what "PV is a public health function" actually looks like in practice — not a slogan on a training slide, but the accumulated effect of individuals choosing accuracy over speed when the two are in tension.