Vinay Kumar K.V

Applied Data Scientist specializing in GenAI and NLP for GxP-Regulated pharmaceutical systems, with 6+ years of experience delivering compliance-critical solutions across global life sciences organizations as Tech Business Analyst/ Product Owner.

My current focus is on the safe, explainable, and audit-ready adoption of AI in regulated environments. I am designing human-in-the-loop GenAI and NLP solutions that support quality, compliance, and operational teams while aligning with GxP, data integrity, and validation expectations.

I am currently building and validating AI prototypes/personal projects that apply NLP and GenAI to unstructured quality data such as deviations, CAPAs, and audit observations, with emphasis on:- Controlled GenAI (RAG, prompt guardrails, traceability)- NLP-based classification, clustering, and trend detection- Explainability, model governance, and validation-friendly design - Risk-based AI adoption aligned to GAMP 5 principles

Alongside my professional work as Technical Business Analyst, I am pursuing advanced academic training in AI:

This combination allows me to bridge practical enterprise delivery with rigorous AI thinking, particularly in highly regulated contexts where both technical depth and governance are critical.

I have worked as a Product Owner/Business Analyst within global pharmaceutical programs, leading requirements definition, GxP documentation (URS, SRS, validation protocols), UAT coordination, and cross-functional stakeholder engagement across quality, IT, and regulatory teams. I am particularly interested in roles and collaborations focused on: - GenAI & NLP in regulated or enterprise environments- Quality, compliance, and operational analytics in life sciences - Scalable and responsible AI adoption in GxP systems If you are working on AI in regulated environments or exploring how GenAI can be operationalized safely, I’m always open to exchanging insights.