Senior Drug Safety Associate Interview Questions and Answers

Questions related to drug safety and pharmacovigilance

• Day zero is the start of a clinical trial or the day of drug administration

• GVP module VI provides guidance on management of periodic safety update reports

• E2B is the international standard for electronic transmission of individual case safety reports

• Antihypertensive drugs are classified based on their mechanism of action, e.g. ACE inhibitors, beta blockers, calcium channel blockers

• Valid case criteria include identifiable pa...read more

Explanation of various terms related to drug safety and pharmacovigilance.

• MedDRA - Medical Dictionary for Regulatory Activities used for coding adverse events

• Spontaneous case - Adverse event reported by healthcare professionals or patients directly to the regulatory authority

• Literature case - Adverse event reported in scientific literature

• Signal detection - Process of identifying potential safety issues from large volumes of data

• Aggregate reporting - Summarizing safety data f...read more

SUSAR stands for Suspected Unexpected Serious Adverse Reaction. ICH R1 and R2 are guidelines for reporting adverse drug reactions. Dechallenge and rechallenge are processes to determine if a drug caused an adverse reaction. MedDRA is a standardized medical terminology used for coding adverse events.

• SUSAR refers to a serious adverse reaction that is both suspected to be caused by the drug and unexpected in its nature.

• ICH R1 and R2 are guidelines established by the Internationa...read more

Clinical trials are research studies that test new treatments on humans. They are conducted in phases to ensure safety and efficacy.

• Phase 1: Small group of healthy volunteers to test safety and dosage

• Phase 2: Larger group of patients to test efficacy and side effects

• Phase 3: Even larger group to confirm efficacy and monitor adverse reactions

• ICH guidelines provide standards for designing, conducting, and reporting clinical trials

• Purpose of clinical trials is to determine safet...read more

Anti-hypertensive drugs are used to lower high blood pressure, while diabetes drugs are used to manage blood sugar levels in diabetic patients.

• Anti-hypertensive drugs work by relaxing blood vessels and reducing the workload on the heart.

• There are several classes of anti-hypertensive drugs, including ACE inhibitors, beta blockers, calcium channel blockers, and diuretics.

• Diabetes drugs can be classified into several categories, including insulin, sulfonylureas, biguanides, and ...read more

Medical devices are classified into different classes based on the level of risk associated with the device.

• Medical devices are classified into Class I, II, or III based on the level of risk they pose to the patient.

• Class I devices are low risk and include items like bandages and tongue depressors.

• Class II devices are moderate risk and include items like infusion pumps and blood pressure monitors.

• Class III devices are high risk and include items like pacemakers and heart valv...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 is the process of monitoring and evaluating the safety and efficacy of drugs.

• It involves the collection, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related problems.

• Pharmacovigilance helps to ensure that drugs are safe and effective for use by patients.

• Examples o...read more