What are different roles in Pharmacovigilance Job?

Hello All,
I hope you are doing great !!!
If you are a fresher or just started your career in Pharmacovigilance (PV) then you must have a lot of queries regarding what are different roles in PV jobs and how to move into these roles?

Don’t worry guys, I am here to help you.

Pharmacovigilance is very dynamic process. In this article we will just see what are the overall roles in pharmacovigilance job. We may go into details in another article.

Roles in ICSR

ICSR is an Individual Case Safety Report and consist of reporting of single patient cases. The majority of the roles are as follows:

Case Triage

Before we proceed for case processing, case triaging is most important and crucial step. Case triaging means to identify if all 4 elements (identifiable patient, identifiable reporter, suspect product and adverse event) are present in the case or not. Based on these elements, it is decided if the case is valid or invalid.

Case processing 

Once the case become valid in case triaging step, then the next step is case processing. It involves all the data entry for reporter, patient, product and event. Along with that narrative writing, labeling assessment and causality assessment.

Quality Review 

Once you process the case then it goes for quality check (QC). It depends on the company conventions if all the cases should be quality reviewed or just 10 to 20% random sampling. It vary from company to company.

Third Party QC 

Some MAH follows this additional QC of cases. i. e. cases which have gone through QC, again reviewed (random sampling) by third party QC team.

Medical Review

Again this is important and crucial step in ICSR processing. Once the case is processed and QC is done then it goes for medical review. This review is performed by Medics or physician (MBBS, MD). They mainly focus on labeling and causality section.

Roles in Aggregate reporting, Signal and RMP

Aggregate report writing and review

Aggregate report is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide. The aggregate report examines and summarizes all existing safety experience with a medicinal product.

Aggregate reports include DSUR, PSUR, PBRER, PADER, ACO etc.

Signal Management

A set of activities performed to determine whether, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking.
The signal management process shall include the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action.

Benefit-Risk Management

An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health.

The risk-benefit balance of a medicinal product is continuously monitored through pharmacovigilance activities and periodical safety reports, such as DSURs and PBRERs.

Additional Roles in PV

PVA (Pharmacovigilance Agreements) and SDEA (safety Data Exchange Agreements)
QPPV (Qualified Person Responsible for Pharmacovigilance)
PSMF (Pharmacovigilance System Master File)
Quality Assurance
Literature review
Study Reconciliation

Please note the designation could be different however, they mostly fall into above categories.

If you have any question or if you know any other roles, please comment so that I can update this article.

PV and Drug Safety

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