Drug Safety Associate 1 Interview Questions and Answers

TB is caused by Mycobacterium tuberculosis and has four stages: exposure, latent infection, active TB disease, and drug-resistant TB.

• TB is caused by the bacterium Mycobacterium tuberculosis.

• The four stages of TB are exposure, latent infection, active TB disease, and drug-resistant TB.

• Exposure occurs when a person inhales the TB bacteria.

• Latent infection is when the bacteria are present in the body but not causing symptoms.

• Active TB disease occurs when the bacteria multiply an...read more

AE stands for Adverse Event, which refers to any untoward medical occurrence in a patient. ADR stands for Adverse Drug Reaction, which specifically refers to a harmful reaction caused by a medication.

• AE is a broader term that encompasses any negative medical event, while ADR specifically relates to medication-induced reactions.

• AE can include events unrelated to medication, such as accidents or natural diseases, while ADR is directly caused by a drug.

• AE can be expected or unex...read more

Case processing involves several steps to ensure accurate and complete reporting of adverse events.

• Receipt of case information

• Data entry and verification

• Coding of adverse events and medications

• Narrative writing

• Quality control and review

• Submission to regulatory authorities

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 concept of cause and effect.

• It is used to determine if a drug or medical device caused an adverse event.

• Causality assessment involves evaluating the temporal relationship, dose-response relationship, and alternative explanations for the event.

• Causality can be difficult to establish in complex medical cases.

• Examples...read more

AE stands for Adverse Event, which is any undesirable experience or effect associated with the use of a medical product. ADR stands for Adverse Drug Reaction, which is a type of AE caused by a medication.

• AE refers to any negative experience or effect associated with the use of a medical product, regardless of whether it is caused by the product or not.

• ADR specifically refers to negative experiences or effects caused by a medication.

• Both AE and ADR are important to monitor and...read more

MedDRA stands for Medical Dictionary for Regulatory Activities. It is a standardized medical terminology used for coding adverse event information.

• MedDRA is used for classifying and coding adverse events in clinical trials and post-marketing surveillance.

• It helps in standardizing the terminology used for reporting adverse events in drug safety.

• MedDRA is maintained and updated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Huma...read more

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

• Pharmacovigilance involves monitoring and evaluating the safety of medications throughout their lifecycle.

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

• PV aims to improve patient safety by identifying and minimizing risks assoc...read more