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M2 Pharmacovigilance and Drug Safety Operations

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This module is part of the learning path to be Qualified Professional in Pharmacovigilance and Drug Safety (QPDS)

What is Module 2?

In this module, the Pharmacovigilance trainee will be able to handle basic steps in drug safety as day-to-day activities (Data collection,  Data Entry in Safety database, Coding of adverse reaction descriptions,  Case causality assessment and Timely reporting to authorities).

Course Content

Module 02: Pharmacovigilance Operations
Pharmacovigilance Department (organization, team, interactions) 1 Quiz
Lesson Content
Case processing of ICSR (Individual Case Safety Report) 1 Quiz
Lesson Content
Medical review and Causality Assessment and Reporting Rules 1 Quiz
MedDRA Coding 1 Quiz
Lesson Content
Literature search and Social Media 1 Quiz
Safety Databases and Training on Oracle Argus Database 1 Quiz
Lesson Content
Drug-Induced Adverse Events 1 Quiz