Top 100 Pharmacovigilance Interview Questions/ Answers

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The WHO defines pharmacovigilance as “the science and actions connected to the detection, assessment, understanding, and prevention of adverse effects or any drug-related problems.” These Pharmacovigilance Interview Questions/ Answers are prepared by experts from Cognizant, Accenture, Novartis, IQVIA, Sanofi-Aventis, Merck, Covance, Pfizer, TCS, Bioclinica, and Syneous health.

Pharmacovigilance Interview Questions/ Answers

Pharmacovigilance Interview Questions for Fresher

Wipro Pharmacovigilance interview questions and answers for freshers Ais provided below:

Question 1. Do you hear about antibiotics? Ans: We can define it as antibiotics are substances produced by various species of microorganisms like bacteria, fungi, etc. that suppress the growth of microorganisms and eventually may kill them.

Question 2. Did you hear the name azithromycin?
Ans: It is a very common antibiotic used in the treatment of bacterial infections like bacterial infections of the tonsils, ear, and nose skin infections stuffed tissues, and lung infections also.

Question 3. is it a narrow spectrum or a broad spectrum?
Ans: It comes under a broad spectrum.

Question 4. what do you mean by broad spectrum?
Ans: For antibiotics, broad-spectrum antibiotics are a kind of antibiotics that are effective against a wide range of organisms or that kind of antibiotics which are act on the two major bacterial groups, gram-positive and gram-negative.

Question 5. how do we differentiate gram-negative and gram-positive bacteria?
Ans: If we do a gram-negative staining process the result of this process is gram-negative takes the violet colors and gram-positive bacteria pink.

Question 6. give some examples of antihypertensive drugs
Ans: Different hypertensive drugs classes are:
ACE inhibitors: ramipril, captopril, and quinapril
ACE antagonist: Telmisartan, valsartan and losartan
Ca Channel blocker: verapamil, amlodipine
Diuretics: Furesamide, methacrylic acid and hydrochlorothiazide
Beta adrenargic blocker: atenolol and propranolol
Alfa adrenargic: Terazosine and Praxosine
Centrally acting: Methyl dopa and clonidine
Adrenergic Nero blocking agent: Reserpine

Question 7. Tell me how ACE inhibitors work.
Ans: ACE means angiotensin-converting enzyme, which is responsible for converting angiotensin I to angiotensin II, Where
angiotensin II is responsible for NaCl reabsorption. ACE inhibitors inhibit the process of converting angiotensin I to angiotensin II which causes decreased NaCl reabsorption and decrease blood pressure also.

Question 8. Where the beta cell is present?
Ans: Beta cell is present in the Heart.

Question 9. Tell me the name of the hormone which is blocked by beta-blocker do you know the name of this hormone?
Ans: It is an epinephrine hormone, Beta blocker works by blocking the effect of this hormone.

Question 10. Some diuretic are used in hyoertension why we use diuretic in hyoertenssion?
Ans: Diuretics work on our kidneys by increasing the amount of salt and water that come out through the urine. too much salt can cause extra flowing to build up in human blood vessels which causes rising blood pressure by flushing salt out from the human body.
Diuretic also causes the wall of the human vessel to relax and wider which makes it easier for blood to flow through this effect also lower blood pressure.

Question 11. What was your Project topic/ Project Thesis?
Ans: Pharmacology and drug development in rare diseases: the attractiveness and expertise of the French medical pharmacology.

Note: The most prevalent mistake that M.Pharm students make is failing to revise their thesis work. Take my word for it: a good interviewer will undoubtedly inquire about your thesis work. Please be comprehensive, and do not provide any replies that allow the interviewer to ask another question. Just be brief, and if you are unsure of the answer, simply state that you do not know.

Question 12. What are Glycolysis and Gluconeogenesis? Ans: Glycolysis: Glycolysis is a process one molecule of glucose is converted into two molecules of pyruvate, two hydrogen ions, and two molecules of water. Gluconeogenesis: It is a metabolic pathway that results in the generation of glucose from certain non-carbohydrate carbon substances.

Question 13. Drug Schedule commonly asked
Ans: Schedule H: This includes being sold under prescription only. E.g. Alprazolam.
Schedule X: Psychotropic drug, the label should contain the warning. E.g. Barbiturates.
Schedule Y: Describe the requirement and guidelines for conducting the clinical trials.

Question 14. What are the different types of diabetes?
Ans: Type I Diabetes: type I diabetes are autoimmune condition, it is also called insulin-dependent diabetes. it happened when the body attacks the pancreas with antibodies. At this time organs become damaged and do not make insulin.

Type II Diabetes: This is non-insulin dependents diabetes. when the pancreas usually creates some insulin but it is not sufficient or the body does not use it.

Question 15. tell me the side effects of losartan.
Ans: Losartan causes pain, burning during urination, shortness of breath, rapid heart rate, pain in the chest, vomiting, and nausea.

Question 16. Tell me the side effects of Amlodipine.
Ans: Amlodipine causes Dizziness and swelling of the feet.

Question 17. Why do we need Pharmacovigilance?

  • Quantify and recognize risk factors Adverse Drug Reactions
  • Unexpected adverse reactions
  • Drug-Drug interactions
  • Long term efficacy

Question 18. 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

Pharmacovigilance Interview Questions for Exprienced Candidates

Question 19. 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.

Question 20. 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 is causally related to medicine.

Question 21. What is the basic minimum required for a valid case?
• An identifiable reporter
• An identifiable patient
• A suspect product
• An adverse drug event

Question 22. When do you think an event is serious?
Ans: If an event is associated with any one of the following:

  • Death
  • Life-threatening
  • hospitalization and prolongation of hospitalization
  • Congenital anomaly
  • Disability
  • Medically significant

Question 23. Name the regulatory bodies.
Ans: CDSCO: Central Drugs Standard Control Organization (India)
USFDA: United States Food and drug administration (USA)
MHRA: Medicines and Healthcare Product Regulatory Agency (UK)
EMEA: European Medicines Agency (EU).
MHLW: Ministry of Health, Labour and Welfare (Japan)
HC: Health Canada (Canada)

Question 24. Name some data elements in ICSR.
Ans: Patient demographics: Age, gender, and race
Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration, and indication
Adverse event details: Event, event onset date, seriousness criterion, event end date, and latency

Question 25. What is Volume 9A?
Ans: Volume 9A brings together general guidance medicinal products in the EU (European Union) on the requirements, procedures, roles, and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).

With the implementation of the new pharmacovigilance laws in July 2012, Volume 9A is being superseded by the European Medicines Agency’s good pharmacovigilance practice (GVP) recommendations.

Question 26. Four parts of Volume 9A are :
Part I: Guidelines for Marketing Authorisation Holders
Part II: Guidelines for Competent Authorities and the Agency
Part Ill: Guidelines for the electronic exchange of pharmacovigilance in the EU Part
Part IV: Guidelines on pharmacovigilance communication

Question 27. What do you mean by MedDRA?
Ans: Medical Dictionary for Regulatory Activities.

Question 28. Tell me the hierarchy in MedDRA.
Ans: System Organ Class (SOC)
High-Level Group Term (HLGT)
High-Level Term (HLT)
Preferred Term (PT)
Lower Level Term (LLT)

Question 29. What are clinical trials?
Ans: A Clinical trial is a comparison test of a medication or other medical treatment (such as medical devices), versus a placebo, other medication or devices, or the standard medical treatment for a patient’s condition.
A clinical trial is an investigation in humans intended to discover or verify the effects of a drug or to identify any adverse reactions to that investigational drug with the object of ascertaining its safety and efficacy.

Question 30. 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.

Question 31. What are the types of Clinical Trials?
Ans: Randomized
Phase I, II, III, IV Trials

Question 32. Can you tell me about the job opportunities after completing this course? Ans: Persons trained in Pharmacovigilance and clinical trials research will find good job options in the following sectors:
Pharmaceutical & Biotech companies
Clinical Research Organizations
Regulatory Agencies like DCG (I) & CDSCO
Pharmacovigilance units in Medical colleges & Hospitals

Basic Pharmacovigilance Interview Questions

Question 33. What are the Basic Principles of Pharmacovigilance?
Ans: Continuous monitoring of the safety of medicines (both old and new) throughout the duration of their use Identification & quantification of ADRs

Question 34. What is a Suspected unexpected serious adverse drug reaction (SUSAR)?
Ans: A serious adverse reaction, in which the nature or severity is not consistent with domestic labeling or market authorization, or expected from characteristics of the drug.

Question 35. What do you mean by Serious Adverse Event or Reaction (SAE)?
Ans: A serious adverse event or reaction is any untoward medical occurrence that at any dose results in death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, or is life-threatening.

Question 36. What is a signal?
Ans: An alert from any available data source that a drug may be associated with a previously unrecognized hazard is quantitatively or qualitatively different from existing expectations.

Question 37. What do you mean by causality?
Ans: In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event.

Question 38. What exactly is the Pharmacovigilance Programme of India (PvPI)?

Ans: The Central Drugs Standard Control Organization (CDSCO), New Delhi, has launched a national pharmacovigilance program under the auspices of the Government of India’s Ministry of Health and Family Welfare. The Indian Pharmacopoeia Commission (IPC) in Ghaziabad coordinates the initiative. The National Coordinating Centre (NCC) recommends methods and guidelines for regulatory interventions in India under the supervision of the Steering Committee.

Question 39. When were GVP guidelines put in place?

Ans: They become effective in July 2012.

Question 40. What is the frequency of the DSUR?

Ans: The first DSUR duration should not exceed one year. The DSUR is always filed once a year.

Question 41. What is the frequency of PADER?

Ans: PADERs were issued quarterly during the first three years. Following then, every year

Question 42. What exactly is an orphan drug?

Ans: A drug (or biological product) used to prevent, diagnose, or cure a Rare Disease, or to diagnose a life-threatening or persistently debilitating disease.

Question 43. What Is a Dead Leg?

Ans: A dead leg is a section of piping where liquid can get stagnant and not be transferred during flushing.

Question 44. What exactly is SAS?

Ans: SAS stands for Statistical Analysis System, which is a collection of software packages.

Question 45. What exactly is polypharmacy?

Ans: Concurrent use of many drugs, sometimes prescribed by separate practitioners.

Question 46. What exactly is VigiBase?

Ans: The WHO Global ICSR Database’s name.

Question 47. What exactly is VigiFlow?

Ans: The UMC developed and maintains VigiFlow, a comprehensive ICSR management system. It can be utilized as the national database for nations participating in the WHO Programme since it includes capabilities for report analysis and makes transmitting reports to VigiBase easier.

Question 48. Roles in Pharmacovigilance
Ans: Drug Safety Associate / Drug Safety Scientist
Pharmacovigilance expert o Drug Safety Physician
Medical reviewer
Pharmacovigilance Executive
Pharmacovigilance associate
Pharmacovigilance – Data Analyst
Pharmacovigilance Scientist
Medical Safety Expert

Question 49. HR round interview question in Pharmacovigilance?

  • Ans: Tell me about your family
  • Where from you, place name
  • Working hours
  • Shifting
  • Off day
  • Facilities
  • Salary discussion
  • Documents

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