Safety Associate Interview Questions and Answers

Updated 1 Dec 2022

Q1. What is PV? What is Causality? What is the classification of Anti hypertensive drugs and their moa? What is the classification of anti cancerous drugs and their moa? What is Adr? What is Meddra? Hierarchy of Me...

Ans.

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

Causality refers to the relationship between a drug and an adverse event, whether the drug caused the event or not.
Anti-hypertensive drugs are classified into several categories, including ACE inhibitors, beta blockers, calcium channel blockers, and diuretics. Each class has a different m...read more

Q2. Tell about pharmacovigilance

Ans.

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 of drugs.
It involves collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems.
Pharmacovigilance helps to identify new ADRs and monitor the safety of drugs already on the market.
It also involves commu...read more

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Q3. What's is Pharmacovigilence

Ans.

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

It involves monitoring and evaluating the safety of drugs and medical devices
It aims to identify and minimize the risks associated with the use of drugs
It involves collecting and analyzing data from various sources such as clinical trials, spontaneous reports, and literature
Examples of pharmacovigilance activ...read more

Q4. Define pharmacovigilance.

Ans.

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 of drugs.
It involves collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems.
Pharmacovigilance helps to identify new ADRs and monitor the safety of drugs already on the market.
It also involves commu...read more

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Q5. Importance of pharmacovigilance

Ans.

Pharmacovigilance is crucial for ensuring drug safety and identifying adverse effects.

Pharmacovigilance helps in monitoring the safety of drugs and identifying any adverse effects that may arise.
It plays a crucial role in ensuring patient safety and preventing harm from medications.
Pharmacovigilance also helps in identifying new safety concerns and updating drug labels accordingly.
Examples of drugs that have been subject to pharmacovigilance include thalidomide, which caused ...read more

Q6. Clinical trials in detail

Ans.

Clinical trials are research studies that test the safety and effectiveness of new treatments or interventions on humans.

Clinical trials are conducted in phases, with each phase having a specific purpose and goal.
Phase 1 trials involve a small group of healthy volunteers to test the safety and dosage of the treatment.
Phase 2 trials involve a larger group of patients to test the effectiveness of the treatment.
Phase 3 trials involve an even larger group of patients to confirm t...read more

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Q7. Difference between ADR and ADE

Ans.

ADR refers to adverse drug reactions while ADE refers to adverse drug events.

ADR is a specific type of ADE that refers to any harmful or unintended reaction to a medication.
ADE is a broader term that encompasses any negative event related to medication use, including errors in prescribing, administering, or monitoring.
Examples of ADRs include allergic reactions, side effects, and toxicity, while examples of ADEs include medication errors, overdoses, and interactions.
Both ADRs...read more

Q8. Explained Causality?

Ans.

Causality refers to the relationship between an event (the cause) and a second event (the effect), where the second event is a result of the first.

Causality is the principle that everything has a cause and effect.
It is used to determine the root cause of an incident or accident.
For example, if a worker falls off a ladder and breaks their arm, the cause may be that the ladder was not properly secured.
Causality can also be used in scientific research to establish cause-and-effe...read more