15 Basic Pharmacovigilance Interview Questions And Answers To Prepare For Interview

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15 Basic Pharmacovigilance interview Questions and Answers

Basic Pharmacovigilance interview questions:

1. Why do we need Pharmacovigilance?
Ans:
Quantify and recognize risk factors for Adverse Drug Reactions
Unexpected adverse reactions
Drug-Drug interactions
Long term efficacy

2. Abbreviations : (Abbreviations are mostly asked during Pharmacovigilance interviews):
Ans: ADE- Adverse Drug Event
ADR- Adverse Drug Reaction
SAE- Serious Adverse Event
CIOMS- Council for International Organizations of Medical Sciences
SUSAR- Suspected Unexpected Serious Adverse Reaction
SSAR- Suspected Serious Adverse Reaction
PSUR- Periodic Safety Update Report
ICH- The International Conference on Harmonization

3.    What is an Adverse Drug Reaction (ADR)?
Ans: An adverse drug reaction (ADR) is an unintended and noxious effect that is attributable to a medicine when it has been given within the normal range of doses.
4.    What is an Adverse Event (AE)?
Ans: An adverse event (AE) is an undesirable occurrence that occurs in the context of drug treatment but may or may not be causally related to medicine.
5.    What is the basic minimum required for a valid case?
Ans:
• An identifiable reporter
• An identifiable patient
• A suspect product
• An adverse drug event

6. What is the basic minimum required for a valid case?
Ans:
• An identifiable reporter
• An identifiable patient
• A suspect product
• An adverse drug event
7. What is the basic minimum required for a valid case?
Ans:
• An identifiable reporter
• An identifiable patient
• A suspect product
• An adverse drug event

8. What is the basic minimum required for a valid case?
Ans:
• An identifiable reporter
• An identifiable patient
• A suspect product
• An adverse drug event
9. What is the basic minimum required for a valid case?
Ans:
• An identifiable reporter
• An identifiable patient
• A suspect product
• An adverse drug event
10. What are the types of Clinical Trials?
Ans: Randomized
Non-Randomized
Single-Center
Multi-Center
Phase I, II, III, and IV Trials
11. Define single and double-blinded studies. Ans: Single Blind Study: A clinical trial where the participant does not know the identity of the treatment received.

Double-Blind Study: A clinical trial in which neither the patient nor the treating investigators know the identity of the treatment being administered.
12. What do you mean by MedDRA?
Ans: Medical Dictionary for Regulatory Activities.

13. What are the ICH guidelines?
Ans: The ICH guidelines provide standards for the development, testing, and registration of pharmaceutical products.
14. What is the role of ICH in pharmacovigilance?
Ans: ICH develops guidelines related to pharmacovigilance, including guidelines on safety reporting and risk management.

15. What is a pharmacovigilance system?
Ans: A pharmacovigilance system is a set of processes and procedures designed to monitor the safety of drugs and report adverse events to regulatory authorities.

50 Advanced Pharmacovigilance Interview Questions and Answers

What is pharmacovigilance? Answer: Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
What is the difference between a serious and non-serious adverse drug reaction (ADR)? Answer: A serious adverse drug reaction is an ADR that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. A non-serious ADR is any ADR that is not serious.
What is signal detection in pharmacovigilance? Answer: Signal detection is the process of identifying new or unrecognized safety concerns related to a drug by analyzing data from various sources, such as spontaneous reports, clinical trials, epidemiological studies, and literature.
What is the difference between pharmacovigilance and clinical trials? Answer: Clinical trials are conducted before a drug is marketed to determine its safety and efficacy. Pharmacovigilance, on the other hand, is the ongoing monitoring of the safety of a drug after it has been approved and marketed.
What is the role of the Pharmacovigilance Risk Assessment Committee (PRAC)? Answer: The PRAC is responsible for assessing and managing the risk of adverse effects of human medicines and providing recommendations to the European Medicines Agency (EMA).
What is the role of the International Conference on Harmonization (ICH) in pharmacovigilance? Answer: The ICH develops guidelines for the pharmaceutical industry to ensure the quality, safety, and efficacy of drugs. Its guidelines for pharmacovigilance provide a framework for the collection, analysis, and reporting of safety data.
What is a Periodic Safety Update Report (PSUR)? Answer: A PSUR is a report submitted by the marketing authorization holder of a drug to regulatory authorities that summarizes the safety information of the drug at defined intervals after its approval.
What is a Risk Management Plan (RMP)? Answer: An RMP is a plan that outlines the safety concerns of a drug and the measures that will be taken to minimize those risks.
What is the difference between a risk and a hazard in pharmacovigilance? Answer: A hazard is a potential source of harm, whereas a risk is the probability that harm will occur.
What is the role of the Data Monitoring Committee (DMC) in clinical trials? Answer: The DMC is responsible for reviewing the safety data of a clinical trial and making recommendations to the trial sponsor and the regulatory authority regarding the continuation or modification of the trial.
What is the difference between an adverse event and an adverse drug reaction? Answer: An adverse event is any untoward medical occurrence that may occur during treatment with a drug, regardless of whether it is related to the drug. An adverse drug reaction is a response to a drug that is noxious and unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy.
What is the role of a safety signal in pharmacovigilance? Answer: A safety signal is information that suggests a new or incompletely documented adverse event that may be caused by a drug.
What is the difference between a spontaneous report and an active surveillance report in pharmacovigilance? Answer: A spontaneous report is a report of an ADR that is submitted voluntarily by healthcare professionals or patients. Active surveillance involves actively collecting data on ADRs through methods such as electronic health records, registry-based surveillance,and prescription event monitoring.
What is the purpose of post-authorization safety studies (PASS) in pharmacovigilance? Answer: The purpose of PASS is to further evaluate the safety of a drug after its approval and marketing, typically in a specific population or for a specific indication.
What is the role of the World Health Organization (WHO) in pharmacovigilance? Answer: The WHO provides global leadership in pharmacovigilance and coordinates international efforts to monitor the safety of medicines.
What is a pharmacovigilance system master file (PSMF)? Answer: A PSMF is a comprehensive document that describes the pharmacovigilance system of a marketing authorization holder, including its organization, procedures, and responsibilities.
What is the difference between a benefit-risk assessment and a risk-benefit assessment in pharmacovigilance? Answer: A benefit-risk assessment evaluates the overall benefit of a drug compared to its risks, while a risk-benefit assessment evaluates the overall risk of a drug compared to its benefits.
What is the role of the European Medicines Agency (EMA) in pharmacovigilance? Answer: The EMA is responsible for the scientific evaluation of medicines in the European Union and monitors the safety of medicines after they have been approved.
What is the difference between a quantitative and a qualitative signal in pharmacovigilance? Answer: A quantitative signal is a signal that is based on numerical data, such as the frequency of a particular adverse event. A qualitative signal is a signal that is based on non-numerical data, such as the nature or severity of an adverse event.
What is the purpose of the EudraVigilance database in pharmacovigilance? Answer: The EudraVigilance database is a centralized database for the collection and analysis of suspected ADRs for medicines authorized in the European Economic Area.
What is the role of the FDA in pharmacovigilance? Answer: The FDA is responsible for regulating the safety and efficacy of drugs in the United States and monitors the safety of drugs after they have been approved.
What is the difference between a population-based and a hospital-based study in pharmacovigilance? Answer: A population-based study involves analyzing data from a general population, while a hospital-based study involves analyzing data from a specific hospital or group of hospitals.
What is the role of the Qualified Person for Pharmacovigilance (QPPV)? Answer: The QPPV is responsible for overseeing the pharmacovigilance activities of a marketing authorization holder and ensuring compliance with regulatory requirements.
What is the purpose of the Medical Dictionary for Regulatory Activities (MedDRA) in pharmacovigilance? Answer: MedDRA is a standardized medical terminology that is used for the classification and coding of ADRs and other medical events.
What is the role of the Drug Safety Monitoring Board (DSMB) in clinical trials? Answer: The DSMB is an independent committee that monitors the safety and efficacy of a clinical trial and makes recommendations to the trial sponsor regarding the continuation or modification of the trial.
What is the difference between a cohort study and a case-control study in pharmacovigilance? Answer: A cohort study follows a group of individuals over time to determine the incidence of a particular adverse event, while a case-control study compares the frequency of a particular adverse event in cases (individuals with the event) and controls (individuals without the event).
What is the role of the Adverse Drug Reaction Electronic System (ADRES) in pharmacovigilance? Answer: ADRES is a web-based platform used by the Philippines Food and Drug Administration (FDA) to report and monitor suspected ADRs of drugs marketed in the Philippines.
What is the difference between a safety signal and a safety alert in pharmacovigilance? Answer: A safety signal is an indication that there may be an increased risk of an adverse event associated with a drug, while a safety alert is a notification to healthcare professionals of a specific safety concern.
What is the role of the Periodic Safety Update Report (PSUR) in pharmacovigilance? Answer: The PSUR is a comprehensive report that provides an updated safety profile of a drug, based on data from clinical trials, post-marketing studies, and other sources.
What is the role of the International Conference on Harmonization (ICH) in pharmacovigilance? Answer: The ICH is a global organization that develops guidelines for the development, registration, and post-marketing surveillance of drugs, including pharmacovigilance activities.
What is the difference between pharmacovigilance and pharmacoepidemiology? Answer: Pharmacovigilance focuses on monitoring and managing the safety of drugs after they have been marketed, while pharmacoepidemiology focuses on studying the effects of drugs in populations.
What is the role of the electronic health record (EHR) in pharmacovigilance? Answer: The EHR can be used to identify potential ADRs and monitor their occurrence in a clinical setting.
What is the role of data mining in pharmacovigilance? Answer: Data mining can be used to identify potential safety signals from large volumes of data, such as electronic health records and social media.
What is the difference between an adverse event and an adverse drug reaction? Answer: An adverse event is any undesirable experience associated with the use of a drug, while an adverse drug reaction is a response to a drug that is noxious and unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy.
What is the role of the Good Pharmacovigilance Practices (GVP) guidelines in pharmacovigilance? Answer: The GVP guidelines provide a set of standards for the conduct of pharmacovigilance activities throughout the European Union.
What is the role of the Signal Detection and Management team in pharmacovigilance? Answer: The Signal Detection and Management team is responsible for identifying and evaluating potential safety signals and making recommendations for further investigation.
What is the difference between a serious and non-serious adverse event? Answer: A serious adverse event is any event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. A non-serious adverse event is any adverse event that does not meet these criteria.
What is the role of the Risk Management Plan (RMP) in pharmacovigilance? Answer: The RMP is a comprehensive plan that outlines the measures that a marketing authorization holder will take to minimize the risks associated with a drug and maximize its benefits.
What is the difference between a black box warning and a contraindication? Answer: A black box warning is the strongest warning that the FDA requires and alerts healthcare professionals and patients to potentially serious or life-threatening risks associated with a drug. A contraindication is a situation where the use of a drug is not recommended due to potential harm to the patient.
What is the role of the Patient Safety Organization (PSO) in pharmacovigilance? Answer: The PSO is a private or public organization that is certified by the Agency for Healthcare Research and Quality (AHRQ) to collect, analyze, and report patient safety information, including ADRs.
What is the role of the EudraVigilance database in pharmacovigilance? Answer: The EudraVigilance database is a European Union (EU)-wide database that collects, manages, and analyzes information on suspected adverse reactions to medicinal products authorized in the EU.
What is the role of the Drug Safety Update (DSU) in pharmacovigilance? Answer: The DSU is a monthly bulletin published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) that provides updates on drug safety issues, including new ADRs, changes to prescribing information, and safety alerts.
What is the difference between risk assessment and risk management in pharmacovigilance? Answer: Risk assessment is the process of evaluating the potential risks associated with a drug, while risk management is the process of implementing strategies to minimize those risks.
What is the role of the Vaccine Adverse Event Reporting System (VAERS) in pharmacovigilance? Answer: VAERS is a national vaccine safety surveillance program in the United States that collects and analyzes information on adverse events that occur after vaccination.
What is the role of the Spontaneous Reporting System (SRS) in pharmacovigilance? Answer: The SRS is a system for collecting and analyzing reports of suspected ADRs that are voluntarily submitted by healthcare professionals and patients.
What is the difference between a Type A and Type B adverse drug reaction? Answer: A Type A ADR is a predictable and dose-related ADR that is commonly observed with a drug, while a Type B ADR is an unpredictable, idiosyncratic, and not dose-related ADR that is rare and often serious.
What is the role of the Pharmacovigilance Risk Assessment Committee (PRAC) in pharmacovigilance? Answer: The PRAC is a scientific committee of the European Medicines Agency (EMA) that is responsible for assessing and managing the risks associated with medicinal products.
What is the role of the MedDRA terminology in pharmacovigilance? Answer: MedDRA is a standardized medical terminology used for the classification and coding of ADRs and other medical events.
What is the difference between a drug interaction and a drug-drug interaction in pharmacovigilance? Answer: A drug interaction is a modification of the effect of a drug by another drug or a food, while a drug-drug interaction is a specific type of drug interaction that occurs between two or more drugs.
What is the role of the Center for Drug Evaluation and Research (CDER) in pharmacovigilance? Answer: The CDER is a division of the FDA that is responsible for the regulation of drugs, including the assessment of their safety and efficacy, and the monitoring of their safety after they are approved.

Bonus Questions with answers:

Define volume 9A?
Volume 9A combines international agreements made within the International Conference on Harmonization (ICH) framework and provides general guidelines on the requirements, practises, roles, and activities in the field of pharmacovigilance, for both Marketing Authorization Holders (MAH) and Competent Authorities of medicinal products for human use.

Volume 9A is presented in four parts:
Part I – Guidelines for Marketing Authorisation Holders;
Part II – Guidelines for Competent Authorities and the Agency;
Part III – Guidelines for the electronic exchange of pharmacovigilance in the EU
Part IV – Guidelines on pharmacovigilance communication

What Should A Narrative Comprise?
A narrative includes accurate and succinct facts regarding the report’s origin, patient demographics, medical history, questionable product details, and adverse event details organised in a logical manner.

Define Meddra?
Medical Dictionary for Regulatory Activities.

Mention The Hierarchy In Meddra?

System Organ Class (SOC)
High Level Group Term (HLGT)
High Level Term (HLT)
Preferred Term (PT)
Lower Level Term (LLT)

What Do You Know About E2a, E2b And E2c Guidelines?

E2a: E2a guidelines provide standard language and definitions for important clinical safety reporting concepts. Additionally, it provides instructions on how to handle accelerated (quick) reporting of adverse drug responses throughout the research stage of drug development.
E2b: information on the data components for transmitting Individual Case Safety Reports as well as E2b guidelines for the upkeep of clinical safety data management.
E2c: E2b recommendations for the upkeep of clinical safety data management and details on periodic safety update reports for medications that have been commercially released.

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