Oracle Argus Training

Oracle Argus Interview Questions

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1. Define Pharmacovigilance?

Pharmacovigilance is defined as science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the contrary effects of medications, biological products, herbalism and other medicine.

2. What are the Minimum Criterion Required For A Valid Case?

• An identifiable reporter

• An identifiable patient

• A suspect product

• An adverse drug event

3. Define Adverse Drug Event (ade)?

Any unfortunate medical occurrence in a patient or clinical investigation subject directed a pharmaceutical product and which does not essentially have a causal relationship with this treatment.

 4. Define Adverse Drug Reaction (adr)?

An adverse drug reaction is defined as a "response to a drug which is poisonous and unintended and which happens at doses normally used for prophylaxis, diagnosis  of disease."

5. What Is the Difference Between Ade And Adr?

There is not be a causal relationship between a drug and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.

6. Define volume 9a?

Volume 9A brings together general guidelines 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 combines international agreements reached within the International Conference on Harmonisation (ICH) framework.

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
  
  

 7. When should you Consider A Case To Be Medically Confirmed?

A case is considered to be medically confirmed if it contains at least a single event confirmed or reported by an HCP (Health Care Professional).

8. What is meant By Causality?

Causality is defined as a relationship between a set of factors. In Pharmacovigilance, causality means the relationship between the suspect product and the adverse drug event.

9. Mention Some Data Elements In Icsr?

Patient demographics: Age, gender and race.

Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication.

10. What Should A Narrative Comprise?

A narrative consist of precise and concise information about the source of report, patient demographics, patient’s medical history, suspect product details and adverse event details in an orderly manner.

11. Define Meddra?

Medical Dictionary for Regulatory Activities.

12. 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)