プロフィール詳細

プロジェクトを作成

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Mohit K.に依頼

India

Pharmacovigilance & Quality Assurance Specialist | PV System Validation Expert | GxP Compliance Consultant

プロフィール概要

I am a Pharmacovigilance and Quality Assurance professional with 8+ years of experience leading global PV operations, validation projects, and compliance-driven system governance. My expertise spans both technical and regulatory domains, enabling me to build, validate, and operate audit-ready PV systems compliant with ICH E2B(R3), 21 CFR Part 11, EU Annex 11, and GAMP 5. As Project Lead – PV & QA at HAROM India, I serve as the bridge between regulatory science and system design, overseeing the full lifecycle of an AI-enabled pharmacovigilance database. I lead URS, FRA, RTM, IQ/OQ/PQ, and UAT, author validation and QMS documentation, and ensure inspection-ready compliance through structured deviation/CAPA and change control systems. I collaborate with clients across 45 countries to harmonize PV systems, author and maintain PSMFs, and implement robust QMS frameworks that withstand regulatory scrutiny. My passion lies in process automation, digital compliance, and AI integration to make PV systems faster, smarter, and regulator-ready.

専門分野

• ☆ Pharmacovigilance/Drug Safety Monitoring

サービス

• Writing
• Consulting

Writing Technical Writing

Consulting Operations Consulting

職務経験

Project Lead

HAROM India Pvt Ltd.

4月 2024 - 現在

PV Specialist

Continuum India LLP

8月 2021 - 4月 2024

Senior drug safety associate

Parexel International Private Ltd

12月 2017 - 8月 2021

学歴

Masters in Biotechnology

Panjab University

8月 2015 - 5月 2017

認定資格

• PV Expert

  ACI, Chandigarh

  1月 2025 - 現在