40+ Pharmacovigilance Associate Interview Questions and Answers

Pharmacovigilance (PV) is the science of detecting, assessing, and preventing adverse effects of drugs.

• PV is responsible for monitoring the safety of drugs and ensuring that the benefits outweigh the risks.

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

• PV is important for ensuring patient safety and improving public health.

• Health authorities in the world include the FDA (USA), EMA (Europe), MHRA (UK), TGA (Australia)...read more

The authority in India for pharmacovigilance is the Central Drugs Standard Control Organization (CDSCO).

• The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority for pharmaceuticals and medical devices in India.

• CDSCO is responsible for the approval of new drugs, clinical trials, and post-marketing surveillance of drugs.

• It ensures the safety, efficacy, and quality of drugs and medical devices in the Indian market.

• CDSCO works under the Ministr...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.

• Monitoring and reporting adverse drug reactions (ADRs)

• Assessing the risk-benefit ratio of drugs

• Identifying and evaluating safety signals

• Communicating safety information to healthcare professionals and patients

• Conducting post-marketing surveillance studies

• Ensuring compliance with regulatory requirements

• Collabo...read more

Excipients are inactive substances added to drug formulations to aid in the manufacturing process, enhance stability, improve bioavailability, and ensure patient acceptability.

• Excipients are inert substances that are added to drug formulations.

• They are used to aid in the manufacturing process, such as binding agents, fillers, and lubricants.

• Excipients can enhance the stability of the drug, preventing degradation or chemical reactions.

• They can improve the bioavailability of th...read more

Points to validate an ICSR case

• Ensure the case meets the criteria for an ICSR

• Verify the accuracy and completeness of the information provided

• Check for duplicate cases

• Assess the causality and seriousness of the adverse event

• Ensure the case is reported within the required timeframe

There are no schedules in jurisprudence. This question may not be relevant to the position of Pharmacovigilance Associate.

Schedule P in pharmacy refers to the list of drugs that can be sold without a prescription.

• Schedule P is a classification system used in some countries to categorize drugs that can be sold without a prescription.

• These drugs are considered safe for self-medication and are typically used to treat common ailments.

• Examples of drugs in Schedule P include over-the-counter pain relievers, cough syrups, antacids, and topical creams.

• Schedule P drugs are usually available for purchase ...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 aims to identify and prevent adverse drug reactions (ADRs) and other drug-related problems

• Pharmacovigilance activities include collecting and analyzing data on drug safety, reporting ADRs to regulatory authorities, and imp...read more

GCP stands for Good Clinical Practice. It is a set of guidelines for conducting clinical trials.

• GCP ensures that the rights, safety, and well-being of trial subjects are protected.

• It also ensures that the data generated from the trial is reliable and accurate.

• GCP guidelines cover various aspects of clinical trials such as study design, conduct, monitoring, and reporting.

• GCP is an international standard and is followed by regulatory authorities around the world.

• It comes under ...read more

In pharmacovigilance, a signal refers to a potential link between a drug and an adverse event.

• A signal is a piece of information that suggests a potential association between a drug and a previously unidentified adverse event.

• Signals are generated through the analysis of data from various sources, such as spontaneous reports, clinical trials, and observational studies.

• Signal detection involves identifying patterns or trends in the data that may indicate a safety concern.

• Once ...read more

AE stands for Adverse Event and SAE stands for Serious Adverse Event.

• AE refers to any untoward medical occurrence in a patient or clinical trial subject, which does not necessarily have a causal relationship with the treatment being administered.

• SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congen...read more

Prescription event monitoring is a method of monitoring adverse drug reactions in patients who are prescribed a new drug.

• It involves collecting data on patients who have been prescribed a new drug and monitoring them for any adverse reactions.

• The data collected includes patient demographics, medical history, and details of the drug prescribed.

• This method helps to identify any previously unknown adverse reactions to a drug and can lead to changes in drug labeling or even withd...read more

I have a good grip on pharmacology and general knowledge to understand and report side effects of vaccines.

• I have a degree in pharmacy and have studied pharmacology extensively.

• I keep myself updated with the latest research and developments in the field of pharmacology.

• I have experience working in pharmacovigilance and have reported adverse drug reactions.

• I have a good understanding of the human anatomy and physiology, which helps me in understanding the mechanism of action o...read more

An example of an antibacterial drug is penicillin.

• Penicillin is a widely used antibiotic that is effective against a variety of bacterial infections.

• It was the first antibiotic discovered and has been used for decades to treat various infections.

• Penicillin works by inhibiting the growth of bacteria and preventing them from forming cell walls.

• Other examples of antibacterial drugs include amoxicillin, ciprofloxacin, and erythromycin.

The current Meddra version is MedDRA Version 24.1.

• MedDRA is a standardized medical terminology used for the classification and coding of adverse events and medical product information.

• It is regularly updated to include new terms and improve the accuracy and efficiency of adverse event reporting.

• MedDRA Version 24.1 was released in June 2021 and is the most recent version.

• Pharmacovigilance professionals need to stay updated with the current MedDRA version to ensure accurate cod...read more

An example of an antifungal drug is fluconazole.

• Fluconazole is commonly used to treat fungal infections such as candidiasis and cryptococcal meningitis.

• It belongs to the class of drugs known as azole antifungals.

• Other examples of antifungal drugs include amphotericin B, itraconazole, and terbinafine.

Pharmaceutical departments are specialized divisions within pharmaceutical companies that handle various aspects of drug development, production, quality control, and regulatory compliance.

• Pharmaceutical departments are responsible for research and development of new drugs.

• They conduct clinical trials to test the safety and efficacy of new drugs.

• Pharmaceutical departments oversee the manufacturing and production of drugs.

• They ensure quality control and adherence to regulatory...read more

Medical coding is the process of assigning standardized codes to medical diagnoses and procedures to ensure accurate reporting and billing.

• Medical coding involves using standardized code sets such as ICD-10, CPT, and HCPCS.

• To choose the exact adverse drug reaction (ADR) code, pharmacovigilance associates need to carefully review the patient's medical records, laboratory results, and any other relevant information.

• The ADR code chosen should accurately reflect the specific adve...read more

In case of technical fault in company system, how to handle the situation?

• Report the issue to the IT department immediately

• Document the issue and any potential impact on pharmacovigilance activities

• Implement a backup plan if necessary

• Communicate the issue and any necessary actions to relevant stakeholders

• Ensure that the issue is resolved and preventative measures are taken to avoid future occurrences

Listing refers to the process of documenting and categorizing adverse events or side effects associated with a particular drug or medical product.

• Listing involves collecting and analyzing data on adverse events reported by healthcare professionals, patients, or other sources.

• The information gathered during listing is used to identify potential safety concerns and evaluate the risk-benefit profile of the drug.

• Listing can include documenting the nature and severity of adverse e...read more

Pharmacovigilance is the practice of monitoring and assessing the safety and effectiveness of medications.

• Pharmacovigilance is used to identify and evaluate adverse drug reactions (ADRs) and other medication-related problems.

• It helps in detecting and preventing potential risks associated with the use of medications.

• Pharmacovigilance plays a crucial role in ensuring patient safety and improving the overall quality of healthcare.

• It involves collecting, analyzing, and reporting ...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 the safety of pharmaceutical products after they have been released to the market.

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

• The goal of pharmacovigilance is to improve patient safety and minimize risks associated w...read more

Schedule M is a set of guidelines issued by the Central Drugs Standard Control Organization (CDSCO) in India for the manufacturing and quality control of drugs.

• Schedule M is applicable to all pharmaceutical manufacturers in India.

• It outlines the requirements for premises, equipment, personnel, documentation, and quality control procedures.

• The guidelines cover aspects such as good manufacturing practices (GMP), storage conditions, labeling, and packaging.

• Schedule M also includ...read more

I have 3 years of experience in the pharmacovigilance industry.

• Worked as a Pharmacovigilance Associate at XYZ Pharmaceuticals for 3 years.

• Managed adverse event reporting and case processing.

• Conducted safety data analysis and signal detection.

• Contributed to the development of pharmacovigilance processes and procedures.

• Collaborated with cross-functional teams to ensure compliance with regulatory requirements.

• Participated in audits and inspections by regulatory authorities.

• Staye...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 prevent adverse drug reactions (ADRs) and other drug-related issues.

• Pharmacovigilance activities include collecting and analyzing data on drug safety, conducting risk assessments, and implementin...read more

MedDRA stands for Medical Dictionary for Regulatory Activities.

• MedDRA is a standardized medical terminology used for the classification and coding of adverse events and medical product information.

• It is widely used in pharmacovigilance to facilitate the collection, analysis, and reporting of safety data.

• MedDRA consists of a hierarchy of terms organized into System Organ Classes (SOCs), High-Level Group Terms (HLGTs), High-Level Terms (HLTs), Preferred Terms (PTs), and Lowest ...read more

Instruments of pharmacology should be handled with care and proper knowledge.

• Instruments should be cleaned and sterilized before and after use.

• Proper training and knowledge should be acquired before handling any instrument.

• Instruments should be stored in a safe and secure place.

• Regular maintenance and calibration of instruments is necessary.

• Examples of instruments include syringes, needles, pipettes, and microscopes.

Types of Adverse Drug Reactions (ADRs) and how to attend Regulatory Authorities (RA)

• Types of ADRs include Type A (predictable, dose-dependent), Type B (idiosyncratic, not dose-dependent), Type C (chronic), Type D (delayed), and Type E (end-of-treatment)

• To attend Regulatory Authorities (RA) regarding ADRs, report all suspected adverse reactions promptly and accurately

• Provide detailed information such as patient demographics, medical history, concomitant medications, and descri...read more

The procedure for new drug approval involves several stages including preclinical testing, clinical trials, FDA review, and post-market surveillance.

• Preclinical testing is done in laboratories and on animals to assess the safety and efficacy of the drug.

• Clinical trials involve testing the drug on human subjects to determine its safety and effectiveness.

• The FDA reviews the data from preclinical and clinical studies to decide whether to approve the drug for market.

• Post-market s...read more

Adverse reactions are unwanted effects of drugs that occur at normal doses. Adverse effects are harmful effects of drugs.

• Adverse reactions are usually predictable and dose-dependent.

• Adverse effects can be caused by overdose, drug interactions, or idiosyncratic reactions.

• Examples of adverse reactions include nausea, headache, and dizziness.

• Examples of adverse effects include liver damage, kidney damage, and allergic reactions.

• Pharmacovigilance is the process of monitoring and ...read more

Digestion is the process of breaking down food into smaller molecules that can be absorbed by the body.

• Digestion starts in the mouth where food is chewed and mixed with saliva.

• The food then travels down the esophagus into the stomach where it is further broken down by stomach acid and enzymes.

• In the small intestine, nutrients are absorbed into the bloodstream.

• The remaining waste moves into the large intestine where water is absorbed and the waste is formed into feces.

• Finally,...read more

Data management involves organizing, storing, and analyzing data to ensure its accuracy and accessibility.

• Organizing data in a structured manner

• Storing data securely to prevent loss or unauthorized access

• Analyzing data to extract meaningful insights

• Ensuring data accuracy and completeness

• Maintaining data quality over time

Diabetes is a chronic condition that affects how your body turns food into energy.

• Diabetes is characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both.

• There are three main types of diabetes: type 1, type 2, and gestational diabetes.

• Symptoms of diabetes include frequent urination, increased thirst, unexplained weight loss, and fatigue.

• Treatment for diabetes may include medication, insulin therapy, lifestyle changes, an...read more

Future opinion refers to the anticipated views or beliefs that individuals may hold in the future.

• Future opinion can be influenced by various factors such as advancements in technology, changes in societal norms, and evolving scientific research.

• It is important for pharmacovigilance associates to consider future opinions when assessing the safety and efficacy of pharmaceutical products.

• For example, a drug that is currently considered safe may face backlash in the future due t...read more

Drug dictionaries are used to standardize drug names and facilitate communication between healthcare professionals.

• Drug dictionaries can be national or international

• Examples of national drug dictionaries include the US National Drug Code (NDC) and the UK Dictionary of Medicines and Devices (dm+d)

• International drug dictionaries include the World Health Organization's International Nonproprietary Names (INN) and the Anatomical Therapeutic Chemical (ATC) classification system

• Dru...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

• Pharmacovigilance helps in identifying new drug safety issues and preventing harm to patients

• Examples of pharmacovigilance activities include signal detection...read more

An adverse event is an undesirable and unintended sign, symptom, or medical condition that occurs after using a medication or medical device.

• Adverse events can range from mild side effects to severe reactions.

• They can be caused by medications, vaccines, medical devices, or other healthcare interventions.

• Adverse events should be reported to regulatory authorities for monitoring and evaluation.

• Examples include nausea, headache, allergic reactions, and organ damage.

I am from New York City, USA.

• I was born and raised in New York City.

• I have lived in the USA my whole life.

• I am familiar with the healthcare system in the US.

Terms are encoded using standardized coding systems such as MedDRA or WHO Drug Dictionary.

• Use standardized coding systems like MedDRA or WHO Drug Dictionary

• Assign specific codes to terms based on predefined criteria

• Ensure consistency and accuracy in encoding to facilitate data analysis

DCGI stands for Drug Controller General of India.

• DCGI is the regulatory authority in India responsible for the approval of drugs and clinical trials.

• It ensures the safety, efficacy, and quality of drugs available in the Indian market.

• DCGI grants licenses for manufacturing, sale, and distribution of drugs.

• It also monitors and regulates pharmacovigilance activities in India.

• Example: DCGI approved the emergency use authorization of COVID-19 vaccines in India.

CDSCO stands for Central Drugs Standard Control Organization.

• CDSCO is the national regulatory body for pharmaceuticals and medical devices in India.

• It is responsible for the approval of new drugs, clinical trials, and post-marketing surveillance.

• CDSCO ensures the safety, efficacy, and quality of drugs and medical devices in the country.

• It regulates the import, manufacture, distribution, and sale of drugs and medical devices.

• CDSCO plays a crucial role in pharmacovigilance acti...read more

USFDA stands for United States Food and Drug Administration.

• USFDA is a regulatory agency of the United States government responsible for ensuring the safety and efficacy of food, drugs, medical devices, cosmetics, and more.

• It is a part of the Department of Health and Human Services.

• USFDA regulates the entire lifecycle of pharmaceutical products, from preclinical testing to post-marketing surveillance.

• The agency reviews and approves new drugs, monitors adverse events and safet...read more

Pharmacovigilance involves monitoring, evaluating, and preventing adverse effects of pharmaceutical products.

• Monitoring and reporting adverse drug reactions

• Evaluating the safety profile of drugs

• Identifying and assessing risks associated with medications

• Preventing harm to patients by ensuring safe use of drugs

• Regulatory compliance and reporting to health authorities

• Continuous monitoring of drug safety post-marketing

Four instruments are stethoscope, thermometer, blood pressure monitor, and otoscope.

• Stethoscope is used to listen to heart and lung sounds.

• Thermometer is used to measure body temperature.

• Blood pressure monitor is used to measure blood pressure.

• Otoscope is used to examine the ear canal and eardrum.

The seriousness of a case in pharmacovigilance refers to the potential impact on the patient's health if the adverse event is not addressed.

• Seriousness is determined by factors such as the outcome of the event, the patient's medical history, and the need for medical intervention.

• Examples of serious cases include hospitalization, life-threatening events, disability, and death.

• It is important to assess the seriousness of a case accurately to prioritize reporting and follow-up a...read more

Drugs safety efficacy refers to the balance between the benefits and risks of a medication in real-world use.

• Drugs safety efficacy is crucial in determining the overall impact of a medication on patients.

• It involves assessing the effectiveness of a drug in treating a specific condition while also considering potential side effects.

• Monitoring adverse reactions and conducting post-marketing surveillance are key components of evaluating drugs safety efficacy.