As an IT professional with over 12 years of experience , I provide expert-level consulting at the intersection of Pharmacovigilance, Regulatory Compliance, and Technology.
1. Argus Safety Lifecycle Management
Expert guidance on the industry’s leading Drug Safety platform.
System Upgrades & Implementation: Proven track record of leading upgrades for Argus Safety versions 7.x and 8.x.
Configuration & Optimization: Customizing reporting rules, workflow configurations, and product licenses to meet specific business needs.
Efficiency Gains: Specialized in optimizing implementation timelines, with experience reducing deployment from 3 months to 6 weeks.
Technical Integration: Seamlessly integrating Argus with modules like Mart, Analytics, Insight, and Oracle B2B.
2. PV Data Migration & System Integration
Ensuring data integrity during complex digital transformations.
End-to-End Migration: Overseeing large-scale data migrations from legacy systems to modern PV platforms like Argus and IVP.
E2B Regulatory Reporting: Expertise in E2B R2 and R3 export/import functionality and customization.
SaaS Strategy: Experience leading B2B SaaS platform modules (IQVIA Vigilance Platform) to simplify patient safety processes.
Impact Assessment: Conducting rigorous assessments to ensure technology adoptions drive operational efficiency.
3. GxP Compliance & CSV (Computer System Validation)
Maintaining audit-readiness in a strictly regulated environment.
Validation Excellence: Delivering full-lifecycle validation documentation, including Installation (IQ), Operational (OQ), and Performance Qualifications (PQ).
Global Regulations: Ensuring all IT systems comply with 21 CFR Part 11, GDPR, and EU GMP Annex 11.
Quality Assurance: Background in validating EMA R3 and PMDA R3 compliance for global pharmaceutical markets.
Change Management: Controlling systems through robust change management procedures to ensure ongoing compliance.
4. Strategic Product & Project Management
Bridging the gap between technical requirements and business goals.
Requirement Analysis: Translating high-level product strategy into detailed requirements and prototypes.
Agile Leadership: Applying Scrum methodologies as a Registered Product Owner™ and Scrum Master™ to ensure rapid value delivery.
Vendor Management: Onboarding and managing relationships with PV vendors to align with organizational roadmaps.
Bid Defense & RFPs: Assisting in technical proposals and participating in bid defense for new client acquisitions.
Contact Me
Are you looking to upgrade your safety systems or ensure your next migration is seamless? Let’s discuss how I can add value to your organization.
Email: kunal@highondata.com LinkedIn: Connect with me
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