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About the course:-

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction

Objective of the course:-


Course Syllabus

Topic : 1 Pharmacovigilance (PV)

Topic : 2 Course Content

Topic : 3 Case Processing

Introduction to Oracle Argus Safety Database, Workflow Configuration, Case Numbering, Different icons used during the case processing and their purpose, Different tabs used in case processing , Minimum requirements for a case Book-in, Case Book-in and Data entry, Case Routing Based on workflow, Case Quality check, Medical review, Duplicate case check or verification.

Topic : 4 Narrative Writing

Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database, Processing of all incoming cases in order to meet timelines, Writing a detailed medically oriented description of the events in the form of safety narrative, Assessment of seriousness, expectedness/listedness of Adverse Events, Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries

Course Features

Instructor Live Sessions

There will be allocated hours of instructor with Live classroom and Simultaneously on Online.

Real Time Studies

Live project based on any of the selected use cases on the above selected Domain.


Each class will be followed by practical assignments which can be completed before the next class.

24/7 Support

We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.


Towards the end of the course, you will be working on a project. Sadhana Infotech certifies you as an course Expert based on the project.

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