VIJAYAMAHANTESH CHATTER
Elegant Drugs Pvt. Ltd.
Bengaluru,Karnataka
1
Certification
Detail-oriented and dedicated M. Pharm postgraduate, eager to begin my career in the pharmaceutical industry. I am committed to applying my knowledge, skills, and strong work ethic to contribute to the growth and success of a dynamic organization.
Work History
Pharmaceutical Production & Quality Control traine
- Completed industrial training in tablet, capsule, liquid and packaging operations, gaining exposure to pharmaceutical manufacturing processes.
- Successfully completed more than 150 hours of industrial training.
Education
M-pharm
GPA: 8.11
B-pharm
GPA: 7.8
Skills
Knowledge of ICH & GCP Guidelines
Clinical Data Management: Knowledge of EDC systems (Rave
Veeva)
CTMS
Annotated CRFs
DMP
UAT and understanding of data collection
validation
and cleaning
Understanding of eCRF design
data validation
and query management
Clinical Trial Process: understanding of clinical trial phases
protocol adherence
informed consent
and regulatory guidelines
Pharmacovigilance: Knowledge about Case processing
validity assessment
duplicate check
adverse event identification
and ICSR (Individual Case Safety Report) handling.
Pharmacovigilance Databases: Familiar with Argus Safety and ARISg
Regulatory documentation support
basic dossier preparation (eCTD/CTD)
and assistance in regulatory submissions
Knowledge about Clinical Trial Project Management
Project planning and coordination
Documentation and reporting
Data Accuracy and Integrity Maintenance
Basic knowledge in SQL and Python
Advanced Microsoft Excel: Proficient in pivot tables
VLOOKUP/XLOOKUP
and dynamic charting for data analysis and visualization
Proficient in Microsoft Word
PowerPoint
Power BI & Macros: Basic proficiency in Power BI dashboards and Excel macros.
Time and Project management
Adaptability and Problem solving
Cross-functional Team Collaboration
Communication and organizational skills
Certification
- Clinical data management Certification: Platform: Udemy | Gained knowledge in ICH-GCP, clinical trial phases, eCRF design, DMP, MedDRA coding, CTMS, UAT, annotated CRF, data query management, and EDC tools like Rave and Veeva.
- Pharmacovigilance Certification: Platform: Udemy | Covered topics including ADRs, MedDRA, ICH guidelines, regulatory reporting, causality & seriousness assessment, narrative writing, vaccine vigilance, PV audits, and case processing.
- Certified in “Good clinical Practice” by the national institute on drug abuse-clinical trials network (NIDA)
- Certification in MS-Excel by Great learning
- Data Management for Clinical Research Certification: Platform: Coursera | Vanderbilt University Gained knowledge of clinical research data management, clinical trial data collection, data quality, and research documentation.
Accomplishments
- GPAT Qualified -2024
- Secured 69th rank in Karnataka PG-CET-2025
Hobbies and Interests
Clinical data management, Regulatory affair’s, Pharmacovigilance, Clinical research
Projects
M-pharm project: "Development and evaluation of polyherbal Nanoemulgel comprising leaf extracts of Ocimum sanctum, Morinda oleifera and Mimosa pudica for topical anti-inflammatory activity" (pharmacology department)., B-pharm project: Impact of Barleria prionitis on compound 48/80 induced Allergic reaction in Wistar Rats.
Timeline
Pharmaceutical Production & Quality Control traine
Elegant Drugs Pvt. Ltd.
07.2024 - 07.2024Read More
Government College of Pharmacy
M-pharm
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B V V Sangha’s Hanagal Shri Kumareshwar College of Pharmacy
B-pharm
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