Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Hobbies
Timeline
Generic
Kushumita Chakraborty

Kushumita Chakraborty

Killeen

Summary

Experienced Pharmacovigilance Associate with a proven track record of two years. Possesses comprehensive expertise in Clinical Research, Pharmacovigilance, and Clinical Data Management. Known for flexibility, diligence, strong communication, and interpersonal abilities. Committed to contributing as a dependable and invaluable team member.

Overview

2
2
years of professional experience
1
1
Certification

Work History

Associate - Quality Assurance

Indegene
03.2021 - 05.2023
  • Handling, managing, and reviewing ICSRs from various
    sources. Responsible for checking the accuracy of data entry
    of individual case safety reports into the safety database.
  • Review and evaluate adverse event (AE} case information to
    determine required action based on internal policies and
    procedures. Review all incoming cases to meet timelines.
  • Accountable for performing accurate data capture for
    individual case safety reports. Disposition of valid ICSRs into
    safety database for further processing.
  • Responsibility to check the accuracy and completeness of
    the cases, including Adverse Drug Reactions/Events coding,
    Product coding, medical assessment, causality and
    seriousness assessment and narrative writing.
  • Responsible for reviewing expedited reporting of cases
    within specified regulatory timelines. Also having a
    knowledge of special situation cases.
  • Providing quality work by following Standard Operating
    Procedures (SOP's) with respective project requirements and
    delivering the knowledge to the team members by
    conducting knowledge transfer sessions.

Education

Master's in Technology - Bioinformatics

SASTRA Deemed University
Thanjavur, India
10.2020

Bachelor's in Technology - Bioinformatics

SATHYABAMA UNIVERSITY
Chennai, India
07.2017

Skills

  • Good Clinical Practice (GCP)
  • MeDRA
  • ICSR
  • Pharmacovigilance
  • Clinical Data Management
  • SAS Programming Language
  • Microsoft Outlook, Word, Excel,Powerpoint
  • Interpersonal skill
  • Problem solving skill
  • Team leadership
  • Presentation skills
  • Time Management
  • Active listener

Accomplishments

  • Received 4 rewards, namely- Going the extra mile, make
    it happen, hitting the mark and double Up for showing
    consistency, quality outputs, project improvements and
    dedication towards work.

Certification

  • SAS Programmer Professional Certificate from Coursera (06/2023-08/2023).
  • Pharmacovigilance Aggregate Reporting from Udemy
    (04/2023).
  • ISEP CERTICATION in Clinical Research from XCEL
    Career (11/2020 - 02/2021).

Languages

English
Full Professional
Hindi
Full Professional
Bengali
Native or Bilingual

Hobbies

  • Painting
  • Singing
  • Cooking


Timeline

Associate - Quality Assurance

Indegene
03.2021 - 05.2023

Master's in Technology - Bioinformatics

SASTRA Deemed University

Bachelor's in Technology - Bioinformatics

SATHYABAMA UNIVERSITY

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Kushumita Chakraborty