Summary
Overview
Work History
Education
Skills
Certification
Hobbies and Interests
Languages
Affiliations
Timeline
Generic

Harsh Dubey

Varanasi

Summary

Dynamic and detail-oriented professional with experience at Cognizant Technology Solutions, excelling in regulatory compliance and safety database management. Proven ability to enhance data integrity and documentation practices while collaborating effectively with cross-functional teams. Strong problem-solving skills and a commitment to quality compliance drive successful outcomes in fast-paced environments.

Overview

2
2
years of professional experience
1
1
Certification

Work History

Trainee Junior Data Analyst PV

Cognizant Technology Solutio
Gurugram
09.2024 - 03.2025
  • Performed case processing of Individual Case Safety Reports (ICSRs) in compliance with regulatory timelines and client-specific guidelines.
  • Reviewed and entered adverse event data into safety databases (e.g., Argus), ensuring accuracy and completeness of reported medical and drug information.
  • Assessed seriousness, causality, and listedness of reported adverse events as per company product list and reference safety information.
  • Worked with cross-functional teams to resolve queries and ensure high-quality documentation aligned with pharmacovigilance and regulatory requirements.

Quality Control Intern

Softech Pharma Pvt. Ltd.
Nani Daman
01.2023 - 02.2023
  • Data Integrity: Ensured adherence to data integrity protocols during QA and QC procedures, contributing to accurate documentation and compliance with industry standards.
  • Documentation Practices: Implemented meticulous documentation practices to track and record production and quality control data, emphasizing accuracy and completeness, essential for maintaining data quality in clinical trials.
  • Quality Compliance: Assisted in maintaining quality compliance standards, including Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).

Education

Bachelor of Pharmacy -

Dr. APJ Abdul Kalam University
Lucknow
07.2024

Higher Secondary School -

SS Public School
Varanasi
04.2020

Skills

  • Regulatory Knowledge
  • Effective communication
  • Attention to Detail
  • Problem-Solving Skills
  • Teamwork and collaboration
  • Understanding of GMP
  • Time management
  • Familiarity with ICH guidelines
  • MS Office (Word, Excel, PowerPoint)
  • Safety database management
  • Cross-functional collaboration
  • Professional demeanor

Certification

  • Pharmacovigilance, 3 Months online certification course on Pharmacovigilance by Global Pharma Academy, Pune.
  • Good Clinical Practice, Completed 6 hours of online certification course by NIDA.
  • Data Analytics in Healthcare by Medics in Tech.

Hobbies and Interests

  • Content Creation
  • Travelling
  • Networking
  • Sports

Languages

  • English, Full Professional Proficiency
  • Hindi, Native or Bilingual Proficiency

Affiliations

Quality Control and Quality Assessment

  • Implemented quality control protocols to ensure adherence to regulatory standards and specifications in pharmaceutical manufacturing processes.
  • Conducted rigorous testing and analysis of raw materials, intermediates, and finished products to identify deviations and ensure product consistency and safety.

Timeline

Trainee Junior Data Analyst PV

Cognizant Technology Solutio
09.2024 - 03.2025

Quality Control Intern

Softech Pharma Pvt. Ltd.
01.2023 - 02.2023

Bachelor of Pharmacy -

Dr. APJ Abdul Kalam University

Higher Secondary School -

SS Public School
Harsh Dubey