Pharmacovigilance Scientist Interview Questions and Answers

Module 9 in Pharmacovigilance discusses signals and types of signals in drug safety monitoring.

• Module 9 in Pharmacovigilance defines a signal as reported information on a possible causal relationship between an adverse event and a drug.

• Types of signals include new signals, known signals with increased frequency or severity, and known signals with new aspects.

• Examples of signals include unexpected adverse events, drug interactions, and medication errors.

• Signal detection involv...read more

Pharmacovigilance involves monitoring and assessing the safety of pharmaceutical products, while signal detection is the process of identifying potential safety concerns.

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

• Signal detection in pharmacovigilance involves analyzing data to identify potential signals or patterns that may indicate previously unknown...read more

AE stands for Adverse Event, which is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product. ADE stands for Adverse Drug Event, which is a harmful and unintended reaction to a medication.

• AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

• ADE specifically refers to harm caused by the use of a medication, including side effects, allergic reactions...read more

KUR stands for Known Unknown Risk and DME event refers to Drug-Induced Movement Disorder events.

• KUR refers to risks associated with a drug that are known but not fully understood.

• DME events are adverse events related to movement disorders caused by a drug.

• Examples of DME events include tremors, dystonia, and akathisia.

• Understanding KUR and DME events is crucial in pharmacovigilance for assessing drug safety.