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Aggregate Report writing for Regulatory Compliance

NQR Code:NG-5.5-LS-01296-2023-V1-LSSSDC

  • Old Code: NG-5.5-LS-01296-2023-V1-LSSSDC

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About this Qualification

Job Description

This NOS on Aggregate Report writing for Regulatory Compliance will enable individual to have the capability to independently draft comprehensive Aggregate Reports that adhere to strict regulatory compliance standards, ensuring the accurate and timely submission of critical pharmacovigilance data, and demonstrating proficiency in the application of industry-specific best practices for report writing.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
Pursuing 4th year of 3-year/ 4-years UG In relevant field No Experience None
UG 5th year with Courses related to Medical Sciences No Experience None
4 year UG degree with Courses related to Medical Sciences No Experience None

Progression Pathway

  • N/A

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Module 1: Introduction to life sciences industry and Aggregate Reports N/A Mandatory 10 0.333 5.5
Module 2: Report Structure and Writing Skills for pharmacovigilance reporting N/A Mandatory 10 0.333 5.5
Module 3: Signal Detection and Evaluation for Pharmacovigilance N/A Mandatory 10 0.333 5.5
Module 4: Risk Minimization and Compliance for Pharmacovigilance N/A Mandatory 10 0.333 5.5
Module 5: Application and Emerging Technologies for Pharmacovigilance N/A Mandatory 10 0.333 5.5
Module 6: Case Study N/A Mandatory 10 0.333 5.5