SyncMonk Technologies Interview Questions and Answers

MedDRA is a medical terminology used for coding adverse events. Its current version is 23.1.

• MedDRA stands for Medical Dictionary for Regulatory Activities

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

• The current version of MedDRA is 23.1

• ADR stands for Adverse Drug Reaction, which is any harmful or unintended reaction to a drug

• AE stands for Adverse Event, which is any untoward medical occurrence in a patient

• The main diff...read more

Yes, I plan to pursue a Master's degree in Pharmacology.

• I have always been interested in the pharmacological aspect of drug safety.

• A Master's degree in Pharmacology will help me gain a deeper understanding of drug mechanisms and interactions.

• I plan to continue working while pursuing my degree part-time.

• I believe this will enhance my skills and knowledge as a Drug Safety Associate.

Classification of drugs includes NSAIDs, arthritis medications, and antimalarials, each serving distinct therapeutic purposes.

• NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): Used to reduce inflammation and relieve pain. Examples: Ibuprofen, Naproxen.

• Drugs for Arthritis: Target inflammation and pain in joints. Examples: Methotrexate, Sulfasalazine.

• Drugs for Malaria: Antimalarial medications used to treat or prevent malaria. Examples: Chloroquine, Artemisinin.

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

• Pharmacovigilance helps in identifying new safety concerns and taking appropriate actions to minimize risks

• Examples of pharmacovigilance activities include si...read more

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 an event can cause another event to occur.

• It involves identifying a relationship between a potential cause and an observed effect.

• Causality can be established through various methods, including randomized controlled trials and observational studies.

• For example, smoking is a known cause of lung cancer...read more

Causality refers to the relationship between a cause and its effect, determining if one event directly led to another.

• Causality is the principle that one event is the result of the occurrence of another event

• It involves determining if there is a direct relationship between a specific cause and its effect

• In drug safety, causality assessment is used to determine if a drug is responsible for an adverse event

• Factors like timing, dose-response relationship, and alternative explana...read more

PV, PSUR, and ICSR are key concepts in pharmacovigilance related to drug safety monitoring.

• PV (Pharmacovigilance): The science of monitoring the safety of drugs post-marketing to identify adverse effects.

• PSUR (Periodic Safety Update Report): A comprehensive report summarizing the safety profile of a drug at regular intervals.

• ICSR (Individual Case Safety Report): A report detailing a specific adverse event experienced by a patient after drug administration.

Half life of a drug refers to the time taken for the concentration of the drug in the body to reduce by half.

• Half life is important in determining the dosing frequency of a drug.

• It is influenced by factors such as metabolism and excretion of the drug.

• Examples of drugs with short half-lives include morphine and fentanyl, while drugs with long half-lives include diazepam and fluoxetine.