Drug Safety Associate 2

10+ Drug Safety Associate 2 Interview Questions and Answers

Updated 16 Jul 2025
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5d ago

Q. Define pharmacovigilance, how you code a case in database.

Ans.

Pharmacovigilance is the science of monitoring, evaluating, and preventing adverse effects of drugs.

  • Pharmacovigilance involves collecting, analyzing, and reporting adverse drug reactions (ADRs)

  • Cases are coded in the database using standardized coding dictionaries such as MedDRA and WHO-DD

  • The coding process involves selecting the appropriate terms to describe the ADR and its severity

  • The coded data is used for signal detection, risk management, and regulatory reporting

2d ago

Q. What do you know about ICH?

Ans.

ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

  • ICH is a global organization that develops guidelines for the pharmaceutical industry.

  • It was formed in 1990 by regulatory authorities and the pharmaceutical industry.

  • ICH guidelines cover topics such as clinical trials, safety, quality, and efficacy.

  • The guidelines are not legally binding, but are widely adopted by regulatory authorities around the world.

  • Examples o...read more

Drug Safety Associate 2 Interview Questions and Answers for Freshers

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3d ago

Q. Can you write narratives?

Ans.

Yes, I am able to write the narrative.

  • I have experience in writing narratives for adverse events and serious adverse events.

  • I am familiar with the regulatory requirements for narrative writing.

  • I have strong attention to detail and can accurately capture all relevant information.

  • I am able to effectively communicate complex medical information in a clear and concise manner.

  • I am proficient in using various narrative writing tools and software.

3d ago

Q. What are the criteria for a valid case?

Ans.

Valid case criteria include identifiable patient, suspect drug, adverse event, and temporal relationship.

  • Identifiable patient information

  • Suspect drug information

  • Adverse event information

  • Temporal relationship between drug and event

  • Supporting medical documentation

  • Exclusion of alternative causes

  • Consistency with known drug effects

  • Reported by qualified reporter

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5d ago

Q. What are the regulatory timelines?

Ans.

Regulatory timelines refer to the timeframes set by regulatory agencies for the approval and monitoring of drugs and medical devices.

  • Regulatory timelines vary depending on the type of drug or device being reviewed and the regulatory agency involved.

  • For example, the FDA has different timelines for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

  • Regulatory timelines can also be affected by factors such as the complexity of the drug or device, the avai...read more

1d ago

Q. Tell me about the processing.

Ans.

Processing involves reviewing adverse event reports, coding and data entry, signal detection, and submission to regulatory agencies.

  • Reviewing adverse event reports for accuracy and completeness

  • Coding and data entry of adverse events into safety database

  • Performing signal detection to identify potential safety concerns

  • Preparing and submitting safety reports to regulatory agencies

  • Collaborating with cross-functional teams to ensure timely and accurate processing

6d ago

Q. How do you handle special situations and medication errors?

Ans.

Medication errors can occur in special situations, impacting patient safety and treatment outcomes.

  • Medication errors can arise from miscommunication during handoffs, e.g., a patient transferring from ICU to a general ward.

  • Look-alike/sound-alike medications can lead to errors; for instance, prescribing 'Celebrex' instead of 'Celexa'.

  • Errors may occur due to complex dosing regimens, such as in chemotherapy, where precise calculations are critical.

  • Special populations, like pediat...read more

4d ago

Q. How do cancer drugs work?

Ans.

Cancer drugs work by targeting specific molecules or pathways involved in the growth and spread of cancer cells.

  • Cancer drugs can inhibit the growth of cancer cells by interfering with their DNA replication or protein synthesis.

  • Some drugs target specific molecules on the surface of cancer cells, blocking signals that promote their growth.

  • Other drugs can stimulate the immune system to recognize and attack cancer cells.

  • Chemotherapy drugs work by killing rapidly dividing cells, i...read more

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Asked in IQVIA

4d ago

Q. What is 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 involves monitoring and evaluating the safety and efficacy of drugs.

  • It includes collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems.

  • Pharmacovigilance also involves communicating information about drug safety to healthcare professionals and the publi...read more

5d ago

Q. What is your experience with pregnancy cases?

Ans.

Pregnancy cases in drug safety involve assessing risks and outcomes for maternal and fetal health during medication exposure.

  • Assess the potential risks of drug exposure during pregnancy, such as teratogenic effects.

  • Collect detailed information on maternal health, medication history, and pregnancy outcomes.

  • Example: A case where a pregnant woman took a medication and the baby was born with a congenital anomaly.

  • Evaluate the timing of drug exposure in relation to critical periods...read more

2d ago

Q. How do you code an event?

Ans.

An event is coded using a standardized dictionary of terms called MedDRA.

  • MedDRA is a hierarchical dictionary with five levels of terms.

  • The event is coded to the most specific term available in MedDRA.

  • If the event is not listed in MedDRA, it can be coded as 'not otherwise specified' or 'unclassified'.

Asked in Cognizant

5d ago

Q. What are your extracurricular activities?

Ans.

I enjoy hiking and exploring new trails in my free time.

  • Hiking is a great way for me to stay active and enjoy nature

  • Exploring new trails allows me to discover new places and challenge myself

  • I often go hiking with friends or family to make it a social activity

3d ago

Q. What is a SUSAR case?

Ans.

SUSAR refers to Suspected Unexpected Serious Adverse Reactions in clinical trials, crucial for drug safety monitoring.

  • SUSARs are serious adverse reactions that are both unexpected and suspected to be related to a drug.

  • They must be reported to regulatory authorities within specific timelines, often within 7 days for serious cases.

  • An example of a SUSAR could be a patient experiencing severe liver toxicity after taking a new medication that was not previously associated with suc...read more

6d ago

Q. QCr role in PV

Ans.

QCr role in PV is to ensure quality control of pharmacovigilance activities to maintain compliance with regulations and standards.

  • QCr (Quality Control reviewer) plays a crucial role in reviewing pharmacovigilance documents and reports to ensure accuracy and compliance.

  • They verify data accuracy, completeness, and consistency to maintain high quality standards.

  • QCr also ensures that pharmacovigilance activities adhere to regulatory requirements and company SOPs.

  • Examples of QCr a...read more

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