Core Objectives and the Five Pillars of PV

Pharmacovigilance operates through five interconnected functions. These are not sequential steps — they operate simultaneously and feed into each other in a continuous cycle throughout a product’s lifecycle.

Detection is not passive. Modern PV systems actively query databases, run scheduled signal detection algorithms, and receive notifications from regulatory authorities about signals detected in other countries. Assessment determines what a detected signal means: is the association causal or coincidental, and what does the incidence look like relative to background rates. Understanding risk factors is what makes a population-level signal clinically actionable.

Prevention and communication only matter if they change behaviour — safety communications must achieve measurable changes in prescriber and patient behaviour, not just be sent. And no benefit-risk assessment is permanent: post-marketing experience may reveal risks — or benefits — that were too rare, too delayed, or too population-specific to appear in the original trials.

A useful way to hold all five pillars in mind at once: imagine a single new signal arriving this week. Detection is the moment it surfaces in a database query or a case report. Assessment is the days that follow, working out whether it’s real and how strong the evidence is. Understanding risk factors happens in parallel — is this signal worse in older patients, or people on a specific concomitant drug? Prevention is the label update or DHCP letter that eventually goes out. And benefit-risk re-evaluation is what happens next quarter, when this signal gets folded into the product’s next PBRER alongside everything else known about it. None of these five wait for the others to finish — they run continuously, on every product, every day.