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Pharmacovigilance

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.

Highlights

 
  • Hands on practice
  • Industry oriented training
  • Resume preparation
  • Interview preparation
  • Internship Opportunity
  • Assignments / Case Study
  • 100% placement support program

Eligibility

Any UG / PG life-science degree graduate (final year or passed out)

Duration

Duration : 2 Months and 6 Months

Course program

Online | Classroom Weekdays | Weekend

Admission Procedure

Fill admission form along with below documents

  •  One photo,
  •  Update resume,
  •  One ID card
  •  Fee payments

Syllabus 

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

COURSES

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