Akshata Potdar
Mumbai
Summary
Proficient Quality Control Reviewer, experienced in adverse event case analysis, quality review, data validation, and MedDRA coding. Ability to identify discrepancies and maintain the quality matrix. Known for ensuring data accuracy and supporting internal audits, ready to drive improvements in safety data management.
Overview
9
9
years of professional experience
Work History
Junior Data Analyst/Quality Control Reviewer
Cognizant Technology Solutions
Mumbai
12.2018 - 06.2024
- Performed a quality review and validation of safety data using the Argus Safety Database.
- Ensured accuracy, completeness, and consistency of case data before submission.
- Identified data discrepancies and coordinated corrections as per SOPs.
- Maintained quality metrics and supported internal audit.
- Reviewed adverse event cases for correct coding, narrative, and timelines.
Drug Safety Associate
Tata Consultancy Services
Mumbai
03.2015 - 04.2018
- Analyze and process SAE and non-SAE datasets.
- Perform MedDRA event coding and WHO-DD drug coding.
- Create an accurate and structured case narrative, ensuring data integrity.
- Assessed causality and expectedness using reference safety documents.
- Conduct peer quality checks.
- Delivered training on data entry standards and quality benchmarks.
- Worked on SAPPHIRE and ARISG safety databases.
Education
M.Pharm - Pharmacology
Institute of Pharmaceutical Education And Research
Wardha06-2014
Skills
- Data analysis, data validation
- Quality review and quality Assurance
- MedDRA coding and WHO-DD coding
- E2B processing documentation and reporting
- SOP Adherence, discrepancy identification, and resolution
- Adverse event data analysis, review, tracking, and reporting
- MS Excel, MS Word, PowerPoint, Outlook
- Regulatory compliance
- Quality control procedures
- Safety data validation
- Case narrative development
- Database management
Affiliations
Industrial Training: Leben Laboratory, Akola. Exposure to data documentation, laboratory records, and compliance standards.
Timeline
Junior Data Analyst/Quality Control Reviewer
Cognizant Technology Solutions
12.2018 - 06.2024
Drug Safety Associate
Tata Consultancy Services
03.2015 - 04.2018
M.Pharm - Pharmacology
Institute of Pharmaceutical Education And Research