Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Publications
Publications
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Aayushi Gupta

Gurgaon,India

Summary

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

Overview

4
4
years of professional experience
6
6
years of post-secondary education

Work History

Pharmacovigilance Assistant

Elites Safety Sciences
Gurgaon, Haryana
12.2021 - 06.2022
  • Enter data into client safety database ensuring accurate entry of assigned cases average 7-8 cases per day..
  • Verify all case information entered at Book-in/Triage ,including confirmation of MedDRA coding of adverse events, according to project specific guidelines.
  • Code concomitant medications, additional suspect medications and medical history
  • Write narrative per client template, query formulations, remove queries that have been answered.
  • Provide support to other product team members as needed.
  • Maintain thorough understanding of all product protocols and scope of work for clinical studies.
  • Communicate problems and issues to product lead in timely manner.
  • Actively participates in project team meetings as required, providing process improvements suggestions.
  • Adheres to required timelines for completion of adverse event data entry.
  • Conducted research, gathered information from multiple sources and presented results.
  • Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.

Executive Quality Assurance

Abbott Healthcare Pvt. Ltd.
Baddi, Himachal Pradesh
07.2018 - 12.2021
  • 1. Training Management
  • To prepare training plan of employees as site as per their job roles.
  • To provide training metrics to Senior Leadership Team.
  • To provide induction to new joinees at plant and introduce them with site procedures. - To prepare plan for yearly GxP trainings.
  • To monitor training compliance at site by providing list of training tasks due for dates and getting them completed before it gets past due.
  • To act as system site administrator and to coordinate with other department training coordinators to resolve issue faced by people at site in training.
  • To resolve ISOtrain (Learning management system) issues in coordination with regional and global team. - To ensure training projects compliance.
  • To align and implement site training procedure with latest guidelines.
  • 2. Documentation
  • To prepare and review documents related to site procedure and upload in software for master document (Standard Operating Procedures, Standard Testing Procedure) and distribution purpose.
  • To ensure compliance of logbooks and records.
  • To provide documents and data to regulatory.
  • To approve artworks as per latest guidelines by regulatory along with regulatory and packaging development team.
  • To act as system site administrator for DARIUS software and to coordinate with Amplexor team for issue resolving.
  • To ensure archival of Batch Processing records.
  • 3. Quality Management System
  • To ensure documentation and execution of tasks of Change Control though Track wise Application.
  • To ensure effective implementation of QMS through SolTRAQs application system.
  • To ensure effective implementation of Change proposed.

Education

Master of Pharmacy - Drug Regulatory Affairs

DIPSAR
Delhi
08.2016 - 07.2018

Bachelor of Pharmacy -

M.I.E.T.
Meerut
08.2012 - 07.2016

Skills

Microsoft Office (MS Word, MS Excel Advance)

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Accomplishments

  • Abbott Excellence Award for representing training system in MHRA Inspection.
  • Abbott Excellence Award in IPQA.
  • Recognized for implementing the project on Effective implementation of Training system at site.

Timeline

Pharmacovigilance Assistant

Elites Safety Sciences
12.2021 - 06.2022

Executive Quality Assurance

Abbott Healthcare Pvt. Ltd.
07.2018 - 12.2021

Master of Pharmacy - Drug Regulatory Affairs

DIPSAR
08.2016 - 07.2018

Bachelor of Pharmacy -

M.I.E.T.
08.2012 - 07.2016

Publications

Review article on "Role of IPR for commercialization of pharma products".

Pages 522-531, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal


Review article on "Cosmetics: Regulatory and market scenario for US and India".

Pages 164-169, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal

Publications

Review article on "Role of IPR for commercialization of pharma products".

Pages 522-531, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal


Review article on "Cosmetics: Regulatory and market scenario for US and India".

Pages 164-169, 2018, Vol 7, Issue 6 - The Pharm Innovation Journal

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