Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Prajwal Tarale

Prajwal Tarale

B.Pharm
Akola,Maharashtra

Summary

To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

7
7
years of professional experience
2018
2018
years of post-secondary education
3
3
Languages

Work History

Pharmacovigilance Safety Reporting Associate

Icon Plc
10.2022 - Current
  • Schedule the report's like CIOMS, MedWatch, E2B(XML), MedWatch 3500A and Quality review for the MDCG form.
  • Expedited the Regulatory reporting of processed case via email, Getaway submission, portal submission as per the regulatory timeline.
  • Submission of periodic report(PADER, DSUR, Quarterly report, submission of line listing etc.)
  • Had a sound knowledge on regulatory intelligence database, and the case scenarios like event seriousness, type of report , mode of submission.
  • Preparation of study management plan and maintenance of regulatory requirement on timely manner and provide the training to the peer group members.
  • Performed bulk reporting in the safety reporting database and resubmission if any negative acknowledgment received.
  • Trained on Global Compliance Tracker, DocuSign 21 CFR Part 11.
  • For medical device, submission of CIOMS, MedWatch 3500A, MDCG, to Health Authority, Central Ethics Committee, IRB Investigators and Licensing Partner as per the study contract.
  • Maintaining the submission compliance report for assign study to mitigate the quality of submission on time.
  • Keep the assign study audit ready with the completion of audit QC checklist and eTMF filling.
  • Successfully handled the Client Qualification Audit, Internal Audit,Client Audit for assign Studies.
  • Good understanding of unite billing for the in-scop activity.
  • Developed and maintained strong relationships with key clients to ensure high levels of satisfaction and won the standalone studies.

Junior Data Analyst

Cognizant
03.2021 - 10.2022
  • Schedule the report's like CIOMS, MedWatch, E2B(XML), MedWatch 3500A and Quality review for the MDCG form.
  • Expedited the Regulatory reporting of processed case via email, Getaway submission, portal submission as per the regulatory timeline.
  • Argus Case finalization
  • Knowledge of MEDDRA, WHODD.
  • Knowledge on ICH guidelines
  • Case processing for the Spontaneous,Post-marketing Surveillance, Literature cases.
  • Enhanced data accuracy by meticulously cleaning and organizing datasets for analysis.

Drug Safety Associate

TCS
10.2018 - 03.2021
  • Case triage, duplicate search using multiple filters like Name, patient number, event term, any worldwide number, author etc.
  • Responsible for ICSR case processing in ARGUS Database.
  • Case triage for the ICSR submission.
  • Quality Check for case processing.
  • Source document retrieval and archiving activity.
  • Worked on unblinding and SafeTrack activity.
  • Assisted in the development and implementation of training materials, contributing to the ongoing education of fellow Drug Safety Associates.

Education

B. Phram -

IPER Collage Wardha, Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU)
Wardha, India

Skills

Case Submission to FDA, EU/EEA

Accomplishments

  • Win the project excellence award for completing project with in defined timeline, SME for Global Compliance Tracker, Appreciation latter zero Audit Finding.
  • Agile award for study set up in Global Compliance Tracker and preparation of study set-up checklist.

Timeline

Pharmacovigilance Safety Reporting Associate

Icon Plc
10.2022 - Current

Junior Data Analyst

Cognizant
03.2021 - 10.2022

Drug Safety Associate

TCS
10.2018 - 03.2021

B. Phram -

IPER Collage Wardha, Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU)

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Prajwal TaraleB.Pharm