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Top 21 Pharmacovigilance Interview Questions.

Top 21 Pharmacovigilance Interview Questions

Success in the Pharmaceutical Industry in today’s World is almost impossible without effective Pharmacovigilance or drug safety monitoring activity. Therefore it is evident that the pharmacovigilance field is growing exponentially, and the growth potential is touching the sky. But, do you know some of the most commonly asked questions in Pharmacovigilance?

Every candidate would prefer to know the questions beforehand while attending the desired interview. Although the below list of questions is not exhaustive, they are some topics you must prepare well.

One would surely face some or most of these questions from the interviewer belonging to the Pharmacovigilance Industry. We, therefore, try to help you with a list of 21 questions that might help you throughout the process. You can look through these questions to understand what the industry expects.

You must be prepared for the interviews if you wish to work for leading pharmaceutical or biotech companies. In this regard, the Pharmacovigilance course designed in BCRI by the industry professional is tailored and custom-made to the need of the industry. One can choose from theoretical as well as practical-based courses. Always ask yourself not what you need but what your enterprise needs while preparing to get your dream job.

Of course, for complete information and understanding of the concept, you need to enroll in the Pharmacovigilance course, which will prepare you for interviews. So, come and learn about the Safety of medicine in the most meaningful way with us.

F.A.Q

Top 21 Pharmacovigilance Interview  questions that might help you throughout the Interview process.

Pharmacovigilance, according to the World Health Organisation’s (WHO) definition is “The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem”.

I need to report to my treating physician immediately and seek medical attention.

It will depend on which country I reside in since every country has different reporting requirements. I must collect all the detailed information pertaining to the case and report to the drug regulatory agency of the country or to the manufacturer.

  1. An identifiable reporter
  2. An identifiable patient
  3. A suspect product
  4. An adverse drug event

No, as it involves a different array of pharmaceutical products like medical devices, biologicals, vaccines, traditional, herbal therapies, and cosmetic products. So, pharmacovigilance is applicable for all of these products.

As ICH E2A guideline describes, Adverse Events are any “untoward medical occurrence” which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to that person.  

According to ICH E2A during the clinical trial, Adverse Reactions are any “noxious and unintended responses” to the product at any dose where the relationship between the product and the reaction “cannot be ruled out.” Once the product has been placed on the market, ADR can be defined as “noxious and unintended” but occur at the established dosages, which have been defined for use in humans to prevent, diagnose, or treat disease or modify “physiological function.”

Both are adverse occurrences while on a drug but if one finds the causality for adverse occurrence it is an adverse drug reaction and if one fails to find causality for adverse occurrence then it is referred to as an adverse event.

In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event.

If an event is associated with any one of the following, it is considered to be serious

  1. Death
  2. Life-threatening
  3. Hospitalization or prolongation of hospitalization.
  4. Congenital anomaly /Birth Defect
  5. Disability
  6. Requiring intervention to prevent permanent damage or impairment
  7. Medically significant

USA: United States Food and drug administration (USFDA).

UK: European Medicines Agency (EMEA).

Japan: Ministry of Health, Labour and Welfare (MHLW).

India: Central Drugs Standard Control Organization (CDSCO)

Phase I studies assess the safety of a drug or device. 

Phase II studies test the efficacy of a drug or device.

Phase III studies involve randomized and blind testing in several hundred to several thousand patients. 

Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale.

Medical Dictionary for Regulatory Activities. It is a standardized dictionary used for coding purposes.

  1. What are the hierarchy in MedDRA.
  • System Organ Class (SOC)
  • High Level Group Term (HLGT)
  • High Level Term (HLT)
  • Preferred Term (PT)
  • Lower Level Term (LLT)
  • System Organ Class (SOC)
  • High Level Group Term (HLGT)
  • High Level Term (HLT)
  • Preferred Term (PT)
  • Lower Level Term (LLT)
  • SUSAR

Suspected Unexpected Serious Adverse Reaction

  • SAE

Serious Adverse Event

  • CIOMS

Council for International Organizations of Medical Sciences

  • ADE

Adverse Drug Event

  • ADR

Adverse Drug Reaction

  • ICSR

Individual Case Safety Report

  • PSUR

Periodic Safety Update Report

  • ICH

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

  • IBD

International Birth Date

  • E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • E2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
  • E2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
  • E2C (R2) Periodic Benefit-Risk Evaluation Report

Two types. 1. Active PV and 2.Passive PV

Active PV: Active (or proactive) safety surveillance means that active measures are taken to detect adverse events.

Passive PV: Passive surveillance means that no active measures are taken to look for adverse effects where voluntary reporting is made by health professionals and others to report safety concerns.

A ‘signal’ consists of reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.

SUSAR is Suspected Unexpected Serious Adverse reaction. Serious adverse drug reaction (SAR) that is unexpected (per the product labels such as USPI, SPC etc.) or for which the development is uncommon (unexpected issue) observed during a clinical trial and for which there is a relationship with the experimental drug, whatever the tested drug or its comparator.

MedWatch form 3500A is used for mandatory reporting in US FDA.

The concomitant medications are the drugs that were started prior to the suspect drug or taken at the same time and continued to take when the suspect drug was administered. The past drugs are defined as the drugs taken prior to start of suspect drugs.

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