Pharmacovigilance Interview Questions Series-3.
Codersdaily brings you the most basic PV interview questions that you must be aware of before you enter any Pharmacovigilance placement drives. Below are questions & answers that will help you kick start your placement prep journey.
Q1: Where is MedDRA used?
Ans: MedDRA is used in the following places:
- Regulatory Authority and Industry Databases
- Individual Case Safety Reports and Safety Summaries
- Clinical Study Report
- Investigators’ Brochures
- Core Company Safety Information
- Marketing Applications
- Prescribing Information
Q2: What is the structure of MedDRA?
Ans: MedDRA has 5 levels structure:
- SOC (System organ class)
- HLGT (High level group term)
- HLT (High level term)
- PT(Preferred term)
- LLT(Lowest level term)
Q3: Which country has its own MTS: PTC?
Ans: MedDRA Term Selection: Points to Consider
Q4: What is the major purpose of MTS: PTC?
Ans: It provides term selection advice for the industry and regulatory purposes. It’s major aim is to promote precise and uniform term selection to simplify the common understanding of data reported.
Q5. What are the MedDRA: Term Selection Points?
Ans: MedDRA term selection points are as follows:
- Diagnoses and Provisional Diagnoses with or without Signs and Symptoms
- Death and Other Patient Outcomes
- Suicide and Self-Harm
- Conflicting/Ambiguous/Vague Information
- Combination Terms
- Age vs. Event Specificity
- Body Site vs. Event Specificity
- Location-Specific vs. Microorganism-Specific Infection
- Modification of Pre-existing Conditions
- Exposures During Pregnancy and Breast-Feeding
- Congenital Terms
- Medical and Surgical Procedures
- Medication Errors
- Accidental Exposures
- Occupational Exposures
- Misuse, Abuse and Addiction
- Transmission of Infectious Agent via Product
- Overdose, Toxicity and Poisoning
- Device-related Terms
- Drug Interactions
- No Adverse Effect and “Normal” Terms
- Unexpected Therapeutic Effect
- Modification of Effect
- Social Circumstances
- Medical and Social History
- Indication for Product Use
- Off Label Use
- Product Quality Issue
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