Pharmacovigilance Interview Tips.

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Pharmacovigilance

• Interview Questions

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• These questions are for those who are looking to
  get a job in pharmacovigilance and want to get an
  idea of pharmacovigilance, however these are just
  some common questions that can be asked. In order
  to obtain more knowledge on pharmacovigilance you
  must go for a course. Pharmamentors provides
  pharmacovigilance training that can help you in
  acquiring knowledge and skills of
  pharmacovigilance and clear your interview.
• Some common pharmacovigilance questions are as
  follows

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What is the difference between adverse drug
reaction and adverse drug event.?

• What is the difference between adverse drug
  reaction and adverse drug event. Adverse drug
  reactions are events where harm is directly
  caused by drugs under appropriate use (i.e at
  normal dose).
• An adverse drug event is harm caused by
  appropriate or inappropriate use of drugs.

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What do you mean by SUSAR?

• Any unfavorable occurrence on a trial participant
  that is judged to have a major impact on their
  health, was not anticipated and could potentially
  due to intervention under investigation is called
  SUSAR.

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What is ICSR?

• Individual case safety reports contain
  information on adverse events or suspected
  adverse reactions associated with medicinal
  products. The information from an ICSR report is
  stored in a safety database.

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What are the validity criterias for ICSR?

• There are 4 validity criterias, they are
• 1) An identifiable reporter
• 2) An identifiable patient
• 3)Suspected medicinal product
• 4) An adverse drug reaction

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What are medwatch forms and CIOMS forms?

• A medwatch form is used to report adverse or
  sentinel events to medwatch. CIOMS form provides
  a standardized format for the reporting of
  adverse drug reactions to any particular
  medicinal product.

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What is causality assessment?

• Causality assessment essentially means finding a
  causal association or relationship between a drug
  and drug reaction.

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What is a safety database?

• Safety databases collect information to
  accurately assess and characterize the risk of a
  new drug.

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What do you mean by ICH-GCP guidelines?

• The International Council for Harmonisation of
  Technical Requirements for Pharmaceuticals for
  Human Use (ICH) Guideline for Good Clinical
  Practice (GCP) is an internationally agreed
  standard that ensures ethical and scientific
  quality in designing, recording and reporting
  trials that involve human subjects.

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What is a serious adverse event?

• A serious adverse event (SAE) in human trials is
  defined as any untoward medical occurrence that
  at any dose results in death, are life
  threatening, require inpatient or prolonged
  hospitalization, results in persistent
  disability/ incapacity or result in congenital
  anomaly/birth defect.

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