Summary
Overview
Work History
Education
Skills
Projects
Languages
Work Recognition
Timeline
Generic

Pratiksha Chavan

Pune

Summary

Pharmacovigilance Professional with 2.5 years of experience in capturing and assessing single adverse event reports associated with client products on a worldwide basis on the client's drug safety database, in accordance with international and local regulatory requirements. Aiming to utilize my strong skills and comprehensive knowledge of pharmacovigilance to ensure the safety and efficacy of drugs for patients.

Overview

2
2
years of professional experience

Work History

Junior Data Analyst

Cognizant
Pune
01.2023 - 06.2025
  • Strong knowledge of MedDRA, WHO Drug Dictionary and coding practices. Triaged, assessed, and perform data entry of adverse event(AE) and serious adverse events accurately using MedDRA.
  • Processed and triaged ICSRs from clinical trials, ensuring timely entry and evaluation in the Argus Safety system.
  • Performed case intake, data entry, medical coding (MedDRA), and quality review for serious adverse events (SAEs).
  • Authored comprehensive narratives and performed causality assessments.
  • Good understanding of the quality and confidentially of patient data and process involved in processing the data to make it presentable as per regulatory requirements.
  • Managed Individual Case Safety Reports of all case types (serious and non-serious cases from spontaneous and solicited programs.

Education

M. Pharm - Quality Assurance

Savitribai Phule University
Pune
01.2022

B. Pharm -

Shivaji University
Kolhapur
01.2020

Higher Secondary Study -

Kolhapur Divisional Board
Kolhapur
01.2016

Secondary Study -

Konkan Divisional Board
01.2014

Skills

  • Case Identification
  • MedDRA Coding
  • Adverse event reporting
  • Observational Skills
  • Quality Compliance
  • Risk assessment
  • Signal Detection
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practices (GVP)

Projects

M. Pharmacy project, Development and Validation of RP-HPLC Method for Simultaneous Estimation of Fluticasone Propionate and Mupirocin in API & its Pharmaceutic Dosage form.

Languages

  • English
  • Hindi
  • Marathi

Work Recognition

Rising star award for quality and productivity

Timeline

Junior Data Analyst

Cognizant
01.2023 - 06.2025

M. Pharm - Quality Assurance

Savitribai Phule University

B. Pharm -

Shivaji University

Higher Secondary Study -

Kolhapur Divisional Board

Secondary Study -

Konkan Divisional Board

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Pratiksha Chavan