Pharmacovigilance Glossary

The fast, first-pass review every incoming safety report goes through, sorting what's urgent from what can wait. Get it right, and genuinely dangerous signals never get buried under routine paperwork.

The structured, scored assessment of whether a medicine actually caused a reported side effect, never just an assumption. Cases get graded on a scale from Certain to Unassessable, and a cluster of Probable or Possible scores is what actually triggers regulators to act.

A statistical technique that flags when a drug and a side effect are reported together far more often than chance alone would predict. It doesn't prove cause and effect; it just tells safety scientists exactly where to look closer.

Health information collected outside the controlled world of a clinical trial: records, claims, registries, and more. It shows how a medicine actually performs once real, messy patients start using it.

A medicine developed for a rare disease so uncommon that ordinary market incentives wouldn't justify the investment. Regulators reward that research with reduced fees, extra guidance, and years of market exclusivity.

The EU committee responsible for assessing safety signals and deciding what regulators should do about them. Its recommendations can update a label, add a Black Triangle, or pull a product from the market.

The EU's centralized safety database, where every suspected side-effect report from across Europe lands in one place. Pooling that data lets safety scientists spot rare, hidden patterns months or years faster than checking each country separately.

The formal document every medicine submits laying out its known risks, its unknowns, and exactly how those will keep being monitored. It's a living plan, updated throughout the medicine's life as new safety data comes in.

The standardized medical vocabulary everyone in pharmacovigilance uses to describe adverse events the same way. It turns a patient's own words into one precise, comparable, and countable term.

The black triangle symbol placed on newly approved medicines, asking doctors and patients to report literally anything unusual they notice. It deliberately lowers the reporting bar during a drug's first years on the market, when only a few thousand trial patients have ever taken it.

The structured record built from a raw report once it's been triaged, coded, and assessed. It's the atomic unit pharmacovigilance runs on, everything downstream gets built by aggregating these, not raw reports.

A harmful, unintended response to a medicine where there's a reasonable possibility the drug caused it. It sits between the wide net of an adverse event and the narrower territory of an already-known side effect.

The requirement to notify regulators about certain cases on a compressed deadline, as fast as 7 calendar days, instead of waiting for routine periodic reporting. Seriousness and expectedness together decide which clock applies.

A Bayesian disproportionality measure used in signal detection that stabilizes estimates for drug-event pairs with only a handful of reports. Often run alongside the simpler Reporting Odds Ratio.

The simplest disproportionality measure, comparing how often an event is reported for one drug against the rest of the database. Easy to compute, but less stable than EBGM when reports are sparse.

A controlled study in human participants, run across phases I through IV, that establishes whether a medicine is safe and effective. Phase IV overlaps directly with pharmacovigilance.

A regulated pathway, also called compassionate use, letting patients with serious conditions access an investigational drug outside a clinical trial. Safety reporting still applies in full.

A study carried out after approval to gather more safety information or measure how well a risk-minimization measure works. Standard practice for many approved medicines, not a red flag.

The medical device equivalent of ongoing safety monitoring, confirming a device's safety and performance stays acceptable throughout its time on the market.

What Real-World Data becomes once it's been properly analyzed, not just collected. Regulators increasingly accept it once the study behind it is rigorous enough.

The legal entity that holds the license to market a medicine and carries the ongoing regulatory responsibility for it. Not necessarily the company that manufactures the product.

The single, named individual an EU marketing authorization holder must appoint, reachable around the clock, with overall responsibility for the company's PV system.

The FDA's safety information and adverse event reporting program, the US counterpart to EudraVigilance. Both a reporting portal and an outbound safety alert system.

The US early-warning system for possible vaccine safety problems, jointly run by the CDC and FDA. Anyone can submit a report, which is why raw counts alone don't prove causation.

A detailed description of an MAH's entire pharmacovigilance system. Usually the first document a regulator asks for during an inspection.

An FDA-required risk management strategy for medicines with serious safety concerns, the closest US equivalent to an RMP. The toolkit scales from a simple medication guide up to restricted, certified dispensing.

The standardized MedDRA term actually used for coding, counting, and reporting a symptom or diagnosis. Everything upstream exists to land on the right one.

A curated grouping of MedDRA Preferred Terms covering one medically meaningful concept, built to catch every way it might have been coded. A search tool, not a signal-detection verdict on its own.

The country-level regulatory body responsible for medicine safety within its own borders, MHRA, BfArM, AEMPS, and so on. PRAC's own membership is built from experts each NCA nominates.

The EU agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines across all member states. It coordinates national authorities rather than replacing them.