Summary
Overview
Work History
Education
Skills
Websites
Languages
AWARDS
AREAS OF INTEREST
PUBLICATIONS 6+ - SCOPUS INDEXED JOURNALS (PG 2023-2025)
PARTICIPATIONS
Timeline
Generic
Vidhi Ansul Saxena

Vidhi Ansul Saxena

Goa

Summary

A highly motivated and detail-oriented M.Pharm Best Outgoing Student & Department Topper in Pharmaceutical Biotechnology with hands-on experience in Regulatory, Pharmacovigilance and Clinical Data Management Operations. I am committed to delivering high-quality results with an eagerness to learn and embrace new technologies. I thrive in collaborative environments and aim to contribute a flexible and resourceful mindset to advancing global regulatory affairs.

Overview

3
3
years of professional experience

Work History

Graduate Intern – Technical Associate

GlaxoSmithKline (GSK)
Global Capability Centre, Bangalore
08.2024 - Current
  • Reviewed and managed regulatory website accountabilities, ensuring compliance with documentation and archiving requirements.
  • Supported EudraVigilance activities, including generating eRMR, line listings, and ICSR management.
  • Gained hands-on expertise in regulatory data management using the Regulatory Vault system.
  • Managed capability-classified documents and regularly updated/maintained the Pharmacovigilance (PV) library.
  • Conducted data analysis for training activities in Global Safety (GS); managed Argus and Power BI training requests.
  • Oversaw group mailbox and process management, including triaging and resolving stakeholder queries.
  • Coordinated internal engagement initiatives such as the quarterly GS Coffee Lottery and weekly GS eNews (drafting and archiving).
  • Supported effective communication with GS stakeholders through both verbal and written channels.
  • Volunteered and contributed to the capability-classified project for PV Onboarding.
  • Assisted in developing integration plans for GS onboarding processes, collaborating with leadership teams and experts.
  • Authored a comprehensive GS Information Management Handbook to improve awareness of GS tools (eArchive, GSORT, GS Network, LOC/SERM Contacts, Travel & Web Accountabilities app).

Intern

Unity Medicare
Pune
11.2022 - 12.2022
  • Medication dispensing, Inventory management, Prescription handling, Patient counselling.

Intern

Lokmanya Hospitals
Pune
08.2022 - 11.2022
  • Hospital operations, Patient counselling, Cardiac catheterisation, Hospital pharmacy, Patient education.

Intern

Eisen Pharmaceuticals
Pune
05.2022 - 06.2022
  • Gained practical experience in manufacturing, QC/QA, microbiology, and regulatory compliance.

Education

M.PHARM - Pharmaceutical Biotechnology

Manipal College of Pharmaceutical Sciences
Udupi
01-2025

B.PHARM -

MIT-WPU School of Health Sciences & Technology
Pune
01-2023

CLASS X & XII -

Kendriya Vidyalaya No.1
Goa
01-2019

Skills

  • Veeva Vault (Quality, RIM)
  • eTMF management
  • Study documentation
  • Archival (GDMS)
  • Regulatory data management
  • CTMS workflows
  • ICH-GCP guidelines
  • Pharmacovigilance case processing
  • MS Office
  • SharePoint
  • Argus Safety
  • Power BI
  • Cross-functional collaboration
  • Process improvement
  • Metrics tracking

Languages

  • English
  • Hindi

AWARDS

  • Qualified GATE, 02/2022
  • Qualified GPAT, 03/2023
  • Global Recognition Award from GSK, 5 eCards.
  • Best Outgoing Student of M.Pharm in Pharmaceutical Biotechnology, 06/2025
  • Academic Excellence Award for standing first in I-year of M.Pharm Pharm Biotechnology, 02/2025
  • Recipient of the Achievers Scholarship for academic excellence in first year of M.Pharm, 06/2024
  • Achieved a band score of 7.5 in the IELTS exam, 11/2022
  • Achieved I Rank in National Poster Making Competition, 09/2022
  • Achieved II Rank in National Level E-Poster Competition, 11/2021

AREAS OF INTEREST

  • Regulatory Data Management
  • Regulatory Information Management System (RIMS)
  • Regulatory Submissions
  • Regulatory Publishing (eCTD Compilation)
  • Regulatory Labelling and Artwork Compliance
  • Pharmacovigilance
  • Product Lifecycle Management
  • Regulatory Documentation
  • Good Documentation Practices (GDP)

PUBLICATIONS 6+ - SCOPUS INDEXED JOURNALS (PG 2023-2025)

  • Monitoring Drug Safety: The Role of Signal Detection in Pharmacovigilance (Under GSK)
  • Filgrastim Biosimilars Under the Lens: Molecular Integrity to Patient Outcomes (Under GSK)
  • Biomarkers in Breast Cancer Detection, Diagnosis and Prognosis
  • Dysregulated B-cell Receptors in Autoimmunity: From Molecular Signatures to Therapeutic Strategies

PARTICIPATIONS

  • CTMS, Regulatory Training (EU, UK), Study Management, SERM Technical Associate, Clinical Support, and Payments (GSK Internal Modules), 2024-25
  • Gained foundational knowledge in ‘Data Management for Clinical Research’, Coursera, 01/2025
  • Hands-on workshop: ‘Research Ethics- An Update’, Research Ethics, Regulations and Clinical Trials Vertical, CDSCO, India, 08/2024
  • Present Participated in international & national symposia, Translational Oncology, Translational Research in Drug Development, Student Research Congress.

Timeline

Graduate Intern – Technical Associate

GlaxoSmithKline (GSK)
08.2024 - Current

Intern

Unity Medicare
11.2022 - 12.2022

Intern

Lokmanya Hospitals
08.2022 - 11.2022

Intern

Eisen Pharmaceuticals
05.2022 - 06.2022

M.PHARM - Pharmaceutical Biotechnology

Manipal College of Pharmaceutical Sciences

B.PHARM -

MIT-WPU School of Health Sciences & Technology

CLASS X & XII -

Kendriya Vidyalaya No.1
Vidhi Ansul Saxena