How to Prepare yourself for a Pharmacovigilance Interview - For Experienced ICSR professionals

This post on preparing for a Pharmacovigilance interview (for experienced ICSR professional) is very generic but will covers most of the aspects related to ICSR; positive thoughts and comments appreciated.

General Questions :

1. Tell me about yourself ?
2. What were the roles and responsibilities you handled in your previous organization ?
3. What prompted you to choose a career in Pharmacovigilance and why this company (company of the recruiter) ?
4. What was the reason for leaving the previous organization ? And why in such a short duration or why after such a long duration (depending upon the candidate) ?
5. What are you biggest strengths and weakness ?
6. Where do you see yourself in 3 or 5 years ?
7. What is your current CTC and expected CTC and why should we pay you that ?

Skills/Technical Questions

1. What are IME and DMEs ? and who publishes these ?
2. Which ICH guideline outlines the fields to be captured in an ICSR to be reported electronically?
3. What are the reporting timelines for non-serious ICSR in the European Union and affiliated countries ?
4. Is reporter causality mandatory for a clinical trial report; if you dont have it at the time of report, how will you process the ICSR ?
5. As per GPV Module 6, what type of Lack of Efficacy (LoE) are considered serious by default ?
6. What is the causality assessment scale used by the French regulatory authorities and mention the criteria involved in the assessment.
7. What is the difference between Drug Misuse, Drug Abuse and Off-Label Use ? How are medication errors different from these ?
8. What is the current and the latest version of MedDRA; and what is the frequency of MedDRA.
9. When are pharmaceutical companies expected to upgrade their MedDRA dictionary in an unanimous manner to keep data consistent ?
10. What do you mean by a Multi-Axial term in MedDRA ? Which MedDRA SOC has no Multi-Axial term ?
11. What are the mandatory fields to be captured in a death cases ?
12. What is expectedness and what is listedness ? and what is the difference between them (if any) ?
13. What is a SUSAR, in which phase of drug cycle safety does it originate and the document which is used to assess it.
14. What are the minimal safety information or mandatory criteria which you look-in before creating or registering a literature case in the safety database ?
15. What citation format is used in Literature ICSR ?

Current Trends in Pharmacovigilance

1. What is the difference between E2B R2 and E2B R3 (Current Trends in PV). From when is E2B R3 effective ?
2. What is GDPR and HIPPA guidelines and what are its implications on Pharmacovigilance Outsourcing (Current Trends in PV).
3. What is your understanding of RPA (Robotic Process Automation) and Arificial Intelligence in Pharmacovigilance ? Will it impact the outsourcing trends and job cuts ?

Best of Luck !!