UNIT 3: Adverse Event Terminology and Safety Concepts
This unit explains all core adverse event–related terminology used in Pharmacovigilance, exactly as applied in real clinical and regulatory settings. It builds clear differentiation between commonly confused terms and incorporates seriousness criteria, special safety situations, and regulatory interpretations exactly aligned with standard PV notes and practice.
Definition
Any unwanted, undesired, untoward reaction that occurs after drug administration at normal doses for its intended purpose.
Key Points
Usually predictable and listed in the drug information.
Has a known or suspected causal relationship with the drug.
Example: Nausea after taking antibiotics.
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