40+ Qinecsa Solutions Interview Questions and Answers

Product abuse is intentional misuse of a product, while product misuse is unintentional or accidental use of a product.

• Product abuse is a deliberate act of using a product in a way that is not intended or recommended, often for recreational purposes or to achieve a high.

• Product misuse, on the other hand, is the unintentional or accidental use of a product in a way that is not recommended or intended.

• Examples of product abuse include using prescription drugs recreationally, us...read more

Adverse event refers to any undesirable medical occurrence, while reaction is a specific response to a drug or medical intervention.

• Adverse event is a broader term that encompasses any negative medical occurrence, whether or not it is related to a drug or medical intervention.

• Reaction specifically refers to a response to a drug or medical intervention.

• Adverse events can include things like falls, infections, or other medical issues that may or may not be related to a drug or ...read more

Adverse drug event refers to any untoward medical occurrence associated with the use of a drug, while adverse drug reaction specifically refers to a harmful reaction caused by a drug.

• Adverse drug event is a broader term that encompasses any negative medical occurrence related to drug use.

• Adverse drug reaction is a subset of adverse drug events and refers to a specific harmful reaction caused by a drug.

• Adverse drug reactions are usually predictable and dose-dependent, while ad...read more

Questions related to drug safety and pharmacovigilance

• Day zero is the start of a clinical trial or the day of drug administration

• GVP module VI provides guidance on management of periodic safety update reports

• E2B is the international standard for electronic transmission of individual case safety reports

• Antihypertensive drugs are classified based on their mechanism of action, e.g. ACE inhibitors, beta blockers, calcium channel blockers

• Valid case criteria include identifiable pa...read more

Clinical research involves testing new drugs or treatments on humans, while pharmacovigilance involves monitoring the safety of drugs already on the market.

• Clinical research is conducted during drug development to determine safety and efficacy.

• Pharmacovigilance involves monitoring the safety of drugs already on the market and identifying adverse reactions.

• Clinical research is typically conducted in a controlled environment, while pharmacovigilance relies on real-world data.

• Cl...read more

The basic requirements in a case are essential elements or conditions that must be met for the case to proceed.

• Clear and concise facts

• Relevant evidence

• Applicable laws and regulations

• Proper documentation

• Objective analysis

• Logical reasoning

• Effective communication

• Timely resolution

Explanation of various terms related to drug safety and pharmacovigilance.

• MedDRA - Medical Dictionary for Regulatory Activities used for coding adverse events

• Spontaneous case - Adverse event reported by healthcare professionals or patients directly to the regulatory authority

• Literature case - Adverse event reported in scientific literature

• Signal detection - Process of identifying potential safety issues from large volumes of data

• Aggregate reporting - Summarizing safety data f...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 important for ensuring the safety of drugs and protecting public health.

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

• MeDraw is not a known term in pharmacovigilance.

• Argus is a pharmacovigilance software deve...read more

Drugs can be classified into different categories based on their therapeutic use, such as diabetic, hypertension, and basic drugs.

• Diabetic drugs are used to manage diabetes and regulate blood sugar levels, such as insulin and metformin.

• Hypertension drugs are prescribed to control high blood pressure, like ACE inhibitors and beta-blockers.

• Basic drugs refer to medications that are commonly used for various purposes, such as pain relievers like acetaminophen and ibuprofen.

There are four types of clinical trials: Phase I, Phase II, Phase III, and Phase IV.

• Phase I trials test the safety and dosage of a new drug on a small group of healthy volunteers.

• Phase II trials test the effectiveness and side effects of a new drug on a larger group of patients with the targeted disease.

• Phase III trials compare the new drug to the current standard treatment on a large group of patients to determine its safety and effectiveness.

• Phase IV trials are conducted af...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 involves monitoring and evaluating the safety of pharmaceutical products.

• It aims to identify and assess adverse drug reactions (ADRs) and other drug-related issues.

• Pharmacovigilance activities include collecting and analyzing data from healthcare professionals, patients, and regulatory autho...read more

Adverse event is any undesirable experience associated with the use of a medical product. Adverse effect is a harmful and unintended reaction to a medical product.

• Adverse event refers to any negative experience that occurs during the use of a medical product, regardless of whether it is related to the product or not.

• Adverse effect refers specifically to a harmful and unintended reaction to a medical product.

• Adverse events can include things like nausea, headache, or dizziness...read more

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

Clinical trials are research studies that test new treatments on humans. They are conducted in phases to ensure safety and efficacy.

• Phase 1: Small group of healthy volunteers to test safety and dosage

• Phase 2: Larger group of patients to test efficacy and side effects

• Phase 3: Even larger group to confirm efficacy and monitor adverse reactions

• ICH guidelines provide standards for designing, conducting, and reporting clinical trials

• Purpose of clinical trials is to determine safet...read more

Adverse Drug Event refers to any harmful or undesirable effect resulting from the use of a medication or drug.

• Adverse Drug Events can range from mild to severe and can affect any part of the body.

• They can occur due to various reasons such as incorrect dosage, drug interactions, allergic reactions, etc.

• Examples of Adverse Drug Events include nausea, vomiting, dizziness, headache, allergic reactions, liver damage, etc.

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

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

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

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.

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

Adverse Drug Reaction is a harmful or unintended response to a medication.

• It can range from mild to severe

• It can occur immediately or after prolonged use

• Examples include nausea, dizziness, and allergic reactions

• ADR reporting is important for drug safety monitoring

Valid case criteria are important for drug safety analysis.

• The case should have a clear indication of the drug being used.

• The case should have a clear description of the adverse event.

• The case should have a clear timeline of events.

• The case should have sufficient medical information to support the adverse event.

• The case should not have any confounding factors that could explain the adverse event.

• The case should be reported within the appropriate timeframe.

• The case should be c...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 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 helps to identify new safety concerns and prevent harm to patients

• Examples of pharmacovigilance activ...read more

I can join within two weeks. Yes, I am proficient in working on exls ppts.

• I can join within two weeks.

• I am proficient in working on exls ppts.

• I have experience creating and editing PowerPoint presentations.

• I am familiar with the features and functions of Excel PowerPoint.

• I can effectively communicate information through PowerPoint slides.

Drug misuse refers to the inappropriate use of prescription or over-the-counter drugs, as well as illegal drugs.

• Taking medication in higher doses than prescribed

• Using someone else's prescription medication

• Using illegal drugs

• Mixing drugs with alcohol

• Not following medication instructions

• Using medication for non-medical purposes

• Using medication for longer than prescribed

• Using medication in a way other than intended

• Using medication to get high

• Using medication to cope with emotion...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 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

ADR stands for Adverse Drug Reaction, which refers to any harmful or unintended effect of a drug. ADE stands for Adverse Drug Event, which is a broader term that includes both expected and unexpected reactions to a drug.

• ADR is a specific type of ADE

• ADR can be caused by a drug's pharmacological properties, interactions with other drugs, or patient factors

• ADEs can include medication errors, allergic reactions, and drug interactions

• Both ADRs and ADEs are important to monitor and...read more

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

• ADR is a harmful or unpleasant reaction caused by a drug, while ADE is any untoward medical occurrence associated with the use of a drug.

• ADR is a subset of ADE.

• ADR is usually used to describe reactions that are known and expected, while ADE is a broader term that includes unexpected reactions.

• Examples of ADRs include nausea, vomiting, and dizziness, while examples of ADEs include medication errors an...read more

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'.

Common drug mechanism involves targeting specific receptors or enzymes to alter physiological processes.

• Drugs can target receptors to activate or inhibit them

• Drugs can target enzymes to increase or decrease their activity

• Examples include beta blockers targeting beta-adrenergic receptors and statins targeting HMG-CoA reductase

• Drug mechanisms can also involve altering ion channels or transporters

MedDRA is a medical terminology used for coding and classifying adverse events and medication errors.

• MedDRA stands for Medical Dictionary for Regulatory Activities.

• It is a standardized dictionary used in pharmacovigilance to ensure consistent reporting and analysis of adverse events.

• MedDRA is regularly updated to include new medical terms and improve coding accuracy.

• The current version of MedDRA is version 24.1 (as of 2021).

AE refers to any untoward medical occurrence in a patient, while ADR specifically refers to a harmful and unintended reaction to a medication.

• AE can include symptoms, signs, diseases, or worsening of pre-existing conditions, while ADR is a subset of AE caused by a medication.

• AE can be expected or unexpected, while ADR is always unexpected.

• Examples of AEs include headache, nausea, or fever, while examples of ADRs include drug-induced liver injury or anaphylaxis.

Labelling refers to the information provided on a product's packaging or container.

• Labelling includes important information such as dosage instructions, warnings, and ingredients.

• In the medical field, labelling is particularly important for ensuring patient safety and proper use of medications.

• Examples of labelled products include prescription medications, over-the-counter drugs, and food packaging.

• Labelling requirements may vary by country or region, and are often regulated ...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

Half life of a drug is the time it takes for the concentration of the drug in the body to be reduced by half.

• Half life is a pharmacokinetic parameter used to determine the rate at which a drug is eliminated from the body.

• It helps in determining the dosing frequency of a drug - drugs with longer half-lives may be dosed less frequently.

• Half life is influenced by factors such as metabolism, excretion, and distribution of the drug in the body.

• For example, the half life of aspirin...read more

Managing a team involves effective communication, setting clear goals, providing support and feedback, fostering collaboration, and recognizing individual strengths.

• Establish open and transparent communication channels

• Set clear goals and expectations for the team

• Provide support and guidance to team members

• Encourage collaboration and teamwork

• Recognize and utilize individual strengths and skills

• Offer constructive feedback and address conflicts promptly

• Promote a positive work en...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 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

ADR is a harmful reaction caused by a drug, while AE is any untoward medical occurrence.

• ADR is a known and expected harmful reaction caused by a drug.

• AE is any untoward medical occurrence that may or may not be caused by a drug.

• ADR is listed on the drug's label as a potential side effect.

• AE can include symptoms, signs, diseases, or worsening of pre-existing conditions.

• Example of ADR: nausea and vomiting from chemotherapy drugs.

• Example of AE: headache or dizziness after taking...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

Adverse drug reactions can be classified into six types.

• Type A: Augmented pharmacological effects

• Type B: Bizarre effects

• Type C: Chronic effects

• Type D: Delayed effects

• Type E: End-of-treatment effects

• Type F: Failure of therapy