Senior Drug Safety Physician Interview Questions and Answers

Definitions in pharmacovigilance refer to the terms and concepts used in the field of monitoring and assessing the safety of pharmaceutical products.

• Pharmacovigilance: The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Adverse Drug Reaction (ADR): Any response to a drug which is noxious and unintended, including lack of efficacy.

• Signal: Information that suggests a new potentially...read more

ICSR criteria refer to the requirements that must be met for an individual case safety report to be considered valid and reportable.

• ICSR must contain identifiable patient information

• ICSR must include details of the suspected drug and adverse event

• ICSR should be reported within the specified timeframe

• ICSR should be assessed for causality and seriousness