I provide consulting services for pharmaceutical organizations looking to improve their Pharmacovigilance systems, regulatory compliance, and technology operations.
With more than a decade of experience working with global PV platforms and regulatory frameworks, I help organizations implement reliable systems, manage complex migrations, and ensure regulatory readiness.
1. Argus Safety Consulting
Support for organizations using or implementing Oracle Argus Safety.
System Implementation & Upgrades
Guidance for new Argus deployments and version upgrades to ensure smooth transitions and minimal disruption.
Configuration & Workflow Design
Design and configuration of reporting rules, workflows, and system settings aligned with business processes.
Performance Optimization
Improving system performance and operational efficiency across safety operations teams.
System Integration
Integration of Argus with clinical systems, regulatory gateways, and reporting tools.
2. PV Data Migration & System Integration
Helping organizations transition safely between pharmacovigilance systems.
Legacy System Migration
Planning and executing migration of safety data from legacy platforms to modern PV systems.
E2B Reporting Support
Configuration and troubleshooting of E2B R2/R3 reporting and regulatory data exchange.
Data Quality & Integrity
Ensuring migrated data meets regulatory expectations and operational needs.
Technology Roadmapping
Evaluating current PV systems and recommending improvements aligned with long-term business goals.
3. GxP Compliance & Computer System Validation
Ensuring pharmacovigilance systems remain audit-ready and compliant.
Validation Documentation
Preparation and review of validation deliverables including IQ, OQ, and PQ documentation.
Regulatory Compliance
Alignment with regulatory requirements including 21 CFR Part 11, GDPR, and EU GMP Annex 11.
Inspection Readiness
Supporting organizations in preparing validated systems for regulatory inspections.
Controlled Change Management
Establishing structured processes for managing system changes while maintaining compliance.
4. PV Technology Strategy & Project Leadership
Helping organizations align technology initiatives with pharmacovigilance strategy.
Requirements & Solution Design
Defining system requirements and translating business needs into technical solutions.
Project & Delivery Leadership
Supporting PV technology projects from planning through implementation.
Vendor & Platform Evaluation
Assessing vendors and PV platforms to support informed technology decisions.
RFP & Bid Support
Technical support for RFP responses, vendor evaluations, and proposal reviews.
Contact
If your organization is planning a PV system upgrade, migration, or regulatory readiness initiative, I would be happy to discuss how I can support your team.
Email: kunal@highondata.com
LinkedIn: Connect with me
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