Pharmacovigilance Drug Safety Associate Interview Questions and Answers

Clinical trials have different phases including Phase 1, Phase 2, Phase 3, and Phase 4.

• Phase 1: Involves a small group of healthy volunteers to determine safety and dosage.

• Phase 2: Involves a larger group to study effectiveness and side effects.

• Phase 3: Involves an even larger group to confirm effectiveness, monitor side effects, and compare to existing treatments.

• Phase 4: Post-marketing surveillance to monitor long-term effects and use in the general population.

An ADR reaction refers to an adverse drug reaction, which is a harmful or unintended response to a medication.

• An ADR reaction can range from mild side effects like nausea or dizziness to severe reactions like anaphylaxis or organ damage.

• These reactions can occur due to various factors such as individual patient characteristics, drug interactions, or dosage errors.

• Monitoring and reporting ADR reactions is crucial in pharmacovigilance to ensure the safety and effectiveness of m...read more

Adverse events are unwanted or harmful effects that occur after the administration of a drug or medical treatment.

• Adverse events can range from mild side effects like nausea or headache to severe reactions like anaphylaxis or organ damage

• They can be expected based on the known pharmacological properties of the drug or unexpected and rare

• Adverse events should be reported to regulatory authorities for monitoring and evaluation

• Examples of adverse events include allergic reaction...read more

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

• Pharmacovigilance involves monitoring the safety of medications post-market approval.

• It aims to identify and evaluate adverse drug reactions (ADRs) and other drug-related issues.

• Pharmacovigilance plays a crucial role in ensuring the safe and effective use of medications.

• Examples of pharmacovigilance activitie...read more