How to switch from ICSR Role to Aggregate Reporting, Signal and Risk Management Role?

However, please specifically focus on

• Module V – Risk management systems (Rev 2)
• Module VII – Periodic safety update report (Rev 1)
• Module IX – Signal management (Rev 1) 
• Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
• Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2)
• Module XVI Addendum I – Educational materials
• ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER)
• ICH guideline E2E Pharmacovigilance Planning 
• ICH guideline E2F on development safety update report
• Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)

Believe me, if you read and understand these guidelines and modules thoroughly, you will be one step closer to your dream job.

This is one of the best and efficient approach to switch from ICSR to other PV roles. I know it’s not easy because your Team Leads and Managers won’t allow or HR will not consider and so on. However, I would suggest keep trying at your best. This worked for many. But, before applying for IJP, please prepare yourself theoretically efficient.

As many of you know walk-in-interview happens for Aggregate reporting, Signal Detection and Risk management, particularly in CROs and BPOs. I would suggest just go with your ICSR experience and try your luck there. Sometimes, when company don’t get core candidates, they might consider you if you have good knowledge about Aggregate reporting, Signal and Risk management. Again, I will re-iterate you should be theoretically prepared.

This is another way to get into these roles. So if you have your friends and colleagues, who are already working into these domains, please contact them and ask to refer you. Also, take their help in interview preparation.

Many people ask us whether to join these courses to get into these roles? My answer is simple, if you can afford then definitely go for it. You will learn a lot of new aspects of pharmacovigilance. But just because of certification, it’s not guarantee that you will get this role.

If you are looking for affordable Pharmacovigilance certification courses, you can click on below training topic for more details:

1] Certificate Course in Pharmacovigilance ICSR Case processing
2] Certificate Course in Pharmacovigilance Aggregate Reporting
3] Signal Detection and Management in Pharmacovigilance
4] Pharmacovigilance Risk Management Plan: Step by Step Guide
5] Mastering Pharmacovigilance Agreements: A Practical Guide
6] Best Practices of Pharmacovigilance System Master File (PSMF)
7] Role of Qualified Person Responsible for Pharmacovigilance
8] Artificial Intelligence in Pharmacovigilance

As you might aware, we have published an eBook for Pharmacovigilance Interview preparation. We have included questionnaires on all important aspects of Aggregate reporting, Signal Detection, Risk management along with ICSR.

Check out this eBook at below link. http://pvdrugsafety.com/index.php/2021/10/30/e-book-for-pharmacovigilance-interview-preparation/

So overall, at least you have to be theoretically well prepared to get your dram job into Aggregate reporting, Signal Detection and Risk management.

I hope this article help you in some way. If you have any query, please contact us at pvdrugsafetyinfo@gmail.com

Regards,

PV Drug Safety Academy