Profile Details

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USD 9 /hr

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Hire Mohit K.

India

USD 9 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ☆ Pharmacovigilance/Drug Safety Monitoring

Services

• Writing
• Consulting

Writing Technical Writing

Consulting Operations Consulting

Work Experience

Project Lead

HAROM India Pvt Ltd.

April 2024 - Present

PV Specialist

Continuum India LLP

August 2021 - April 2024

Senior drug safety associate

Parexel International Private Ltd

December 2017 - August 2021

Education

Masters in Biotechnology

Panjab University

August 2015 - May 2017

Certifications

• PV Expert

  ACI, Chandigarh

  January 2025 - Present