10+ IQVIA Drug Safety Associate Interview Questions and Answers

Abbreviations commonly used in the Pharmacovigilance (PV) and clinical research field.

• PV - Pharmacovigilance

• ADR - Adverse Drug Reaction

• AE - Adverse Event

• SAE - Serious Adverse Event

• CIOMS - Council for International Organizations of Medical Sciences

• ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

• FDA - Food and Drug Administration

• EMA - European Medicines Agency

• IRB - Institutional Review Board

• GCP - Good Clinical Practice

• ICH...read more

Clinical research is a process of testing new drugs or medical devices on humans to determine their safety and efficacy.

• Clinical research involves testing new drugs or medical devices on humans to determine their safety and efficacy

• It is conducted in phases, starting with small studies in healthy volunteers and progressing to larger studies in patients

• The phases of clinical research are Phase I, Phase II, Phase III, and Phase IV

• Good Clinical Practice (GCP) is a set of interna...read more

Pharmacology drug classification with common ADRs

• Pharmacology drugs can be classified into various categories such as analgesics, antibiotics, antihypertensives, etc.

• Common ADRs include nausea, vomiting, diarrhea, dizziness, headache, and allergic reactions.

• Examples of drugs and their ADRs include aspirin (GI bleeding), penicillin (allergic reactions), and lisinopril (cough).

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 essential for ensuring the safety and efficacy of drugs.

• It involves monitoring and analyzing data from various sources, including clinical trials, spontaneous reports, and literature.

• The ultimate goal of pharmacovigilance is to minimize the risks associated with drug use and maximize the ...read more

Antidiabetic drugs are classified into several categories based on their mechanism of action and chemical structure.

• Sulfonylureas stimulate insulin secretion from pancreatic beta cells (e.g. glipizide)

• Biguanides decrease hepatic glucose production and increase insulin sensitivity (e.g. metformin)

• Thiazolidinediones improve insulin sensitivity and decrease insulin resistance (e.g. pioglitazone)

• Dipeptidyl peptidase-4 inhibitors increase insulin secretion and decrease glucagon se...read more

Antihypertensive drugs are used to lower high blood pressure. Example: Lisinopril.

• Antihypertensive drugs are prescribed to treat hypertension or high blood pressure.

• They work by relaxing the blood vessels, reducing the pressure on the walls of the arteries.

• Examples of antihypertensive drugs include ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics.

• Lisinopril is an ACE inhibitor commonly used to treat hypertension and heart failure.

The current version of MedDRA is version 24.1.

• The current version of MedDRA is updated regularly to include new terms and improve coding accuracy.

• MedDRA version 24.1 was released in March 2021.

• Users of MedDRA must ensure they are using the most up-to-date version for accurate coding and reporting.

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 essential for ensuring the safety and efficacy of drugs.

• It involves monitoring and analyzing data from various sources, including clinical trials, spontaneous reports, and scientific literature.

• The ultimate goal of pharmacovigilance is to minimize the risks associated with drug use and ma...read more

Clinical trials have four phases: I, II, III, and IV.

• Phase I: Small group of healthy volunteers, assess safety and dosage

• Phase II: Larger group of patients, assess effectiveness and side effects

• Phase III: Even larger group, compare to existing treatments, monitor side effects

• Phase IV: Post-marketing surveillance, monitor long-term effects and safety

• Each phase must be completed successfully before moving to the next

• The entire process can take several years and millions of doll...read more

Drug abuse/misuse refers to the use of a drug in a way that is not prescribed or intended, leading to negative consequences.

• Drug abuse/misuse can include taking a drug in higher doses than prescribed, using a drug for non-medical purposes, or using a drug in a way that is not intended (e.g. crushing pills to snort or inject them).

• Drug abuse/misuse can lead to a range of negative consequences, including addiction, overdose, and other health problems.

• Examples of drug abuse/misu...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

ICSR stands for Individual Case Safety Report, which is a document that contains information about adverse events or side effects of a drug.

• ICSR is a report that is submitted to regulatory authorities by pharmaceutical companies.

• It contains information about adverse events or side effects of a drug that have been reported by patients or healthcare professionals.

• ICSRs are an important tool for monitoring the safety of drugs and identifying potential safety concerns.

• They are us...read more

Pharmacovigilance (PV) is important for monitoring and evaluating the safety of drugs to ensure patient safety.

• PV helps in detecting and assessing adverse drug reactions (ADRs) to prevent harm to patients.

• It plays a crucial role in identifying new safety concerns and risks associated with drugs.

• PV contributes to the overall benefit-risk assessment of drugs by providing data on their safety profile.

• It helps in improving patient care by promoting safe and effective use of medic...read more

Clinical trial phases include preclinical research, phase 1, phase 2, phase 3, and phase 4.

• Preclinical research involves testing on cells and animals to assess safety and efficacy.

• Phase 1 involves testing on a small group of healthy volunteers to determine safety and dosage.

• Phase 2 involves testing on a larger group of patients to assess effectiveness and side effects.

• Phase 3 involves testing on an even larger group to confirm effectiveness, monitor side effects, and compare ...read more

Drugs can be classified based on their chemical structure, therapeutic use, and legal status.

• Drugs can be classified based on their chemical structure, such as opioids, benzodiazepines, and SSRIs.

• They can also be classified based on their therapeutic use, such as analgesics, antibiotics, and antipsychotics.

• Drugs can also be classified based on their legal status, such as prescription drugs, over-the-counter drugs, and controlled substances.