Pharmacovigilance is a global discipline. Professionals worldwide share safety data daily. But without a common language, misunderstandings can arise. That is why terminology is not just jargon – it is the foundation of effective drug safety. Are you planning to start a career in pharmacovigilance? Or have you just joined a PV team and feel overwhelmed by the many new words and abbreviations? Do not worry. This article explains the most essential pharmacovigilance terminology you will encounter – from basic concepts to advanced terms used by regulatory authorities.

Clear definitions ensure that everyone understands the same thing when a report mentions an adverse event in India or a serious adverse reaction in Europe. Understanding these definitions will help you feel more confident in your new role and improve communication with colleagues worldwide.

What Is Pharmacovigilance?

The starting point in pharmacovigilance terminology is the term pharmacovigilance itself.

Pharmacovigilance (PV) means the science and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems.

Simply put, pharmacovigilance helps keep patients safe by monitoring medicines after they reach the market.

In practice, pharmacovigilance means collecting safety reports, analysing risks, and ensuring medicines remain safe after they are approved and used by patients worldwide.

Adverse Event (AE)

An adverse event (AE) is any unwanted medical occurrence in a patient who has taken a medicine. Importantly, it does not necessarily have a causal relationship with the treatment.

Example: If a patient takes an antibiotic and then breaks a leg, the fracture is still considered an adverse event.

Adverse Drug Reaction (ADR)

Unlike AE, an adverse drug reaction (ADR) is a harmful or unintended response to a medicine where a causal link to the drug is suspected.

Example: A patient who develops a rash after taking penicillin has experienced an ADR.

ADR is one of the most crucial terms in pharmacovigilance terminology.

Serious Adverse Event (SAE)

A serious adverse event (SAE) is any adverse event that:

• Results in death

• Is life-threatening

• Requires hospitalisation or prolongs existing hospitalisation

• Causes disability or permanent damage

• Results in a congenital anomaly or birth defect

SAEs must be reported quickly because they represent significant safety concerns.

Individual Case Safety Report (ICSR)

An Individual Case Safety Report (ICSR) is a structured record of one adverse event case. It typically contains:

• Patient information

• Description of the adverse event

• Suspected medicine(s)

• Reporter details

Pharmaceutical companies and regulators use ICSRs to detect safety issues.

Signal and Signal Detection

In pharmacovigilance terminology, a signal is information suggesting a possible causal relationship between a medicine and an adverse event that was previously unknown or incompletely documented.

Signal detection involves analysing multiple sources of data (ICSRs, scientific literature, databases) to identify safety concerns that may require regulatory action.

MedDRA: Medical Dictionary for Regulatory Activities

A key tool in pharmacovigilance terminology is MedDRA.

MedDRA is a standardised international medical terminology for classifying adverse events, symptoms, and diagnoses.

Example: Instead of reporting a headache as “head pain,” “migraine,” or “pressure in the head,” MedDRA provides a consistent coding system that allows global comparison and analysis.

Good Pharmacovigilance Practices (GVP)

GVP refers to guidelines developed by the European Medicines Agency (EMA). They describe the minimum standards for conducting pharmacovigilance.

These guidelines explain how companies and regulators should collect, assess, and report safety data to protect patients.

EudraVigilance

EudraVigilance is the European database for managing and analysing ICSRs. Pharmaceutical companies and health authorities submit reports here.

It is one of the most critical systems in modern pharmacovigilance terminology, as it allows large-scale monitoring of medicines across the European Union.

CIOMS

The Council for International Organizations of Medical Sciences (CIOMS) plays a significant role in pharmacovigilance.

CIOMS publishes guidelines and reports that shape international safety standards.

Example: CIOMS forms have historically standardised adverse event reporting before electronic systems became dominant.

Risk Management Plan (RMP)

An RMP is a document required for every new medicine. It describes known and potential risks, how these will be monitored, and what measures will minimise them.

RMPs are crucial in ensuring that medicines remain safe throughout their lifecycle.

Periodic Safety Update Report (PSUR)

Pharmaceutical companies submit a PSUR (also called a PBRER – Periodic Benefit-Risk Evaluation Report) at defined intervals.

It summarises global safety data, evaluates risks, and demonstrates that the medicine’s benefits outweigh its risks.

Benefit-Risk Assessment

Another cornerstone of pharmacovigilance terminology is benefit-risk assessment. This is the ongoing evaluation of whether the benefits of a medicine justify its risks.

Based on this assessment, regulators may update product information, restrict use, or even withdraw a medicine from the market.

Why Learning Pharmacovigilance Terminology Matters

Suppose you are preparing for a pharmacovigilance interview. Questions often begin with definitions because recruiters want to see whether you can clearly explain the difference between AE, ADR, SAE, and a signal. However, terminology is not just about interviews – it shapes everyday work, from entering cases into safety databases and coding events in MedDRA to writing Individual Case Safety Reports (ICSRs) and communicating with health authorities. 

Without a solid grasp of these basics, drug safety tasks quickly become confusing and error-prone. Mastering pharmacovigilance terminology is therefore essential for anyone working in drug safety, as it enables clear communication, ensures compliance with regulatory requirements, and builds confidence in handling safety data. Suppose you are at the beginning of your career. In that case, this glossary provides the foundation you need, and with time, you will expand your knowledge as new abbreviations and definitions appear. Still, these are the most essential building blocks.