SDShilpi Dixit
@shilpidixit
Senior Business Analyst specializing in HealthTech and regulated SaaS with pharmacovigilance expertise.
IndiaWhat I'm looking for
I am a Senior Business Analyst with 5+ years' experience in HealthTech and regulated SaaS, focused on pharmacovigilance systems and regulatory compliance (GxP, 21 CFR Part 11). I lead business requirement analysis, create BRD/FRD, define user stories and acceptance criteria, and drive end-to-end UAT to deliver compliant, high-quality software.
I have hands-on experience with SQL-based data validation, JSON/API validation, MedDRA/WHO-DD workflows, and integration testing, and have partnered with product, engineering, and QA teams to reduce post-release defects and improve data quality. I mentor analysts, run documentation and design walkthroughs, and have improved release efficiency and clinical data quality through targeted workflow and validation enhancements.
Experience
Work history, roles, and key accomplishments
Senior Business Analyst
RxLogix Corporation Pvt. Ltd.
Apr 2023 - Present (2 years 9 months)
Led end-to-end business requirement analysis, functional validation, and UAT for pharmacovigilance SaaS modules, reducing post-release defects by 20% and improving release efficiency by 10%.
Clinical Data Analyst
RxLogix Corporation Pvt. Ltd.
Oct 2021 - Mar 2023 (1 year 5 months)
Managed clinical data validation and functional coordination for PV workflows, validated JSON outputs and coordinated builds via AWS S3 to ensure regulatory alignment and integration across platforms.
Data Tagging Specialist
RxLogix Corporation Pvt. Ltd.
Sep 2020 - Sep 2021 (1 year)
Annotated medical entities for AI/ML datasets using Prodigy and managed datasets via Putty, delivering high-accuracy labeled data to support model training and quality validation.
Education
Degrees, certifications, and relevant coursework
Kanpur University
Bachelor of Science in Nursing, Nursing
2016 - 2020
Completed a Bachelor of Science in Nursing program focusing on clinical nursing education and patient care principles from 2016 to 2020.
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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