Pharmacovigilance is known as Drug Safety, as we know Pharmacovigilance is the pharmacological science that works on adverse event data of pharmaceutical products for data detection, data collections, data assessment, and data prevention. This is an advanced and comprehensive adverse events management system that helps enable regulatory compliance, integrated safety, and risk management.
Oracle Argus Safety is a Drug Safety Database application for processing, analyzing, and reporting adverse event cases.
This course will provide you with a complete understanding of the pharmacovigilance and drug safety methodologies, knowledge to the level expected of healthcare, IT, CRO, from Pharmacovigilance Professional.
- Hands on practice
- Industry oriented training
- Resume preparation
- Interview preparation
- Internship Opportunity
- Assignments / Case Study
- 100% placement support program
EligibilityAny UG / PG life-science degree graduate (final year or passed out)
DurationDuration : 2 Months and 6 Months
Course programOnline | Classroom Weekdays | Weekend
Fill admission form along with below documents
- One photo,
- Update resume,
- One ID card
- Fee payments
Module 1– Introduction of Pharmacolvigilance
Module 2 – History of Pharmacolvigilance
Module 3 – Various definition used in Pharmacolvigilance
Module 4 – Global database (Argus and Arisg)
Module 5 – Guideline and regulatory authority of various countries
Module 6 – Medra coding
Module 7 – Casualty assessments
Module 8– Narrative writing
Module 9 – Case processing /End to end case processing.
Types of case :
- Clinical trial case
- Spontaneous case
- NIS cases
Module 10 – Case submission process to regulatory authority