AKSHATA MOHITE
Navi Mumbai
Summary
B.Pharm graduate with PG Diploma in Clinical Research and clinical and healthcare data management experience in regulated environments. Proficient in clinical data review, data entry, validation, discrepancy management, and quality checks with SOP compliance. Experienced in pharmacovigilance case processing, including AE/SAE handling, ICSR workflow, seriousness and severity assessment, causality review, and MedDRA coding basics.
Overview
3
3
Languages
1
1
Certification
8
8
years of professional experience
Work History
Clinical Trial Associate
Biosphere Clinical Research
Mumbai, India
01.2026 - 07.2026
- Supported clinical trial safety data processing and documentation.
- Reviewed AE/SAE information for completeness and consistency.
- Assisted with case intake, data entry, validation and discrepancy resolution.
- Supported follow-up of missing safety information.
- Assisted with case quality checks and maintenance of accurate safety documentation.
- Worked according to GCP, SOPs and applicable clinical-trial procedures.
Executive Data Analyst & Business Development
DRS SMART SOLUTION PVT LTD.
Navi Mumbai
03.2025 - 11.2025
- Handling large-scale Pan-India datasets across sales, service, and operations.
- Generated MIS reports and analysed sales trends, target vs achievement, and regional performance.
- Designed Excel dashboards to track key metrics and ensure data accuracy.
- Collaborated with teams, streamlined reporting, and supported business growth through insights.
Clinical Data Associate
Inventurus Knowledge Solutions (MNC)
Navi Mumbai
01.2022 - 01.2023
- Managed clinical data for pharmaceutical and healthcare clients, including data abstraction into EHR systems ensuring accuracy and integrity.
- Performed data entry, cleaning, discrepancy management, and validation checks with quality control measures.
- Developed SOPs, supported testing, and collaborated with study teams to resolve data issues.
- Prepared Excel datasets for analysis, improved healthcare delivery, and reduced processing time.
Product Manager Trainee
Leogard Pharmaceuticals Pvt Ltd
Mumbai
01.2021 - 12.2021
- Worked in manufacturing of medical instruments and devices for measurement, testing, and navigation (excluding optical instruments).
- Developed strong understanding of pharmaceutical supply chain and market dynamics.
- Conducted competitive analysis to identify opportunities and challenges.
- Supported product vision and strategy for new pharmaceutical products.
Summer Internship
Sanjivani Paranterals
Navi Mumbai
01.2019 - 12.2019
- Worked in manufacturing and export of generic and branded pharmaceutical products focused on quality and affordability.
- Observed injectable manufacturing processes with strict quality control and assurance.
- Gained experience in packaging, storage, and compliance with Good Manufacturing Practices.
Education
PG Diploma - Clinical Research
Institute Of Good Manufacturing Practices
01.2021
Bachelor of Pharmacy(B. Pharm) -
Bombay College of Pharmacy
01.2020
Skills
- Proficiency in electronic data capture (EDC) systems
- Good Clinical Practice (GCP)
- Electronic data capture (EDC)
- Data management
- Clinical data management
- Advanced Excel
- Tableau
- Scientific Writing & Communication
- Research & Analytical Skills
- Continuous learner
- Time management & multitasking
- Safety reporting
- Regulatory compliance
- Data validation
Certification
- Navigo Analytics, Bombay College Of Pharmacy, 2023
- Data Analyst in Health Care
Languages
English
Advanced
C1
Hindi
Advanced
C1
Marathi
Advanced
C1
Projects
Market-Based Study on LASA Drug Brand
Conducted extensive market research identifying 67 high-risk LASA drugs., Analyzed dispensing errors through surveys and field validation. Proposed tech-driven solutions to improve medication safety.
Timeline
Clinical Trial Associate
Biosphere Clinical Research
01.2026 - 07.2026
Executive Data Analyst & Business Development
DRS SMART SOLUTION PVT LTD.
03.2025 - 11.2025
Clinical Data Associate
Inventurus Knowledge Solutions (MNC)
01.2022 - 01.2023
Product Manager Trainee
Leogard Pharmaceuticals Pvt Ltd
01.2021 - 12.2021
Summer Internship
Sanjivani Paranterals
01.2019 - 12.2019
PG Diploma - Clinical Research
Institute Of Good Manufacturing Practices
Bachelor of Pharmacy(B. Pharm) -
Bombay College of Pharmacy