QINECSA SOLUTIONS | BIOCLINICA Mysore, India
Drug Safety Associate I Jul 2021 - Jul 2022
TATA CONSULTANCY SERVICES Mumbai, India
Senior process associate Apr 2018 - Jul 2021
As a Drug Safety Associate:
- Identified valid cases, performed an initial evaluation of reported adverse events, conducted duplicate searches, and data entry of ICSR into global safety databases. Ensured accurate and consistent coding of all adverse events and evaluated causality, seriousness, and listedness of AE in accordance with company policies. Performed follow-up via Call/postal mail/email, to obtain missing information for safety data.
- As a Quality Reviewer, reviewed cases for accuracy, consistency, and completeness of data captured in PV safety databases, recorded, and shared timely feedback, and ensured that corrections to cases were incorporated as per guidelines agreed with the pharmaceutical company and FDA.
As a Human Bio-samples Data Manager:
- Managed data for Human Biological Samples (HBS) generated on-site using an SAP-based HBS tracking tool. Developed and implemented comprehensive sample data management plans for each study, aligning them with the protocol, study reference manual, and other relevant documents. Assisted the SAP/HBS custodian in project activities to ensure study milestones and timelines were met.
- Ensured proper storage and disposal of collected samples in accordance with the clinical protocol, patient informed consent, regulatory requirements, biohazard guidelines, and international transport guidelines when applicable.
- Conducted quality checks and maintained accurate data for team activities, overseeing quality dashboards for effective monitoring.
- Supported the filing and review of Trial Master File (TMF) documents to ensure completeness and compliance.
VIRIDIS BIOPHARMA PVT LTD Mumbai, India
R&D executive Mar 2017 – Apr 2018
M/S. GEO CHEM LABORATORIES PVT. LTD Mumbai, India
Trainee quality control Microbiologist Jul 2014 – Aug 2015
