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
Udupi01-2025
B.PHARM -
MIT-WPU School of Health Sciences & Technology
Pune01-2023
CLASS X & XII -
Kendriya Vidyalaya No.1
Goa01-2019
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
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