CHAITANYA KULKARNI

Strategic Pharmacovigilance Leader with 17+ years of expertise in architecting global PV systems, driving large-scale digital transformations, and ensuring peak regulatory readiness. Proven track record in reducing operational expenditure by 30% through the strategic development of in-house centers of excellence and the implementation of advanced safety databases (ARGUS/ARISg). Expert in navigating complex global landscapes, including post-Brexit EU/UK transitions and successful MHRA GPvP inspections. A results-driven executive skilled in balancing rigorous compliance with commercial agility, providing high-level oversight on aggregate reporting (PSURs/RMPs), signal management, and benefit-risk strategy. Recognized for fostering a culture of innovation, mentoring high-performing global teams, and serving as a key advisor to senior leadership on global safety risks and operational optimization.

• Safety Infrastructure: Enterprise-level implementation & validation of Argus (v8.4) and ARISg.
• Digital Transformation: Expertise in PV automation, AI-integrated case intake workflows, and data migration strategy.
• Quality Management: PSMF (PV System Master File) architecture and maintenance
• Collaborative Ecosystems: Advanced utilization of MS 365 (Teams/SharePoint) for global team synchronization and project governance.

• Global Change Management: Leading organizational transitions (e.g., post-Brexit strategy, Canada-to-India transitions).
• Executive Influence: Expert in high-stakes Negotiation and Conflict Resolution with health authorities and business partners.
• P&L & Resource Planning: Strategic headcount forecasting, vendor selection, and 30% cost-reduction through in-house team development.
• Succession Planning: Mentorship of mid-level managers to build a sustainable leadership pipeline.

• Category: High-Impact Achievement
• Regulatory Leadership: Spearheaded the 2020 MHRA GPvP Inspection for Bristol Laboratories, resulting in a successful outcome with zero critical findings through rigorous audit readiness and quality system optimization.
• Global Strategy: Architected the Post-Brexit PV Continuity Plan for UK/EU markets; designed and deployed harmonized quality systems and processes to ensure 100% regulatory compliance during major geopolitical transition.
• Operational Excellence: Orchestrated a 30% reduction in global operational costs by leading the strategic transition of PV systems from Canada to India (Apotex) and building high-performance in-house teams for Alkem and Marksans Pharma.
• Digital Transformation: Directed the end-to-end implementation and validation of ARGUS v8.4; modernized the global safety infrastructure, enhanced data integrity, and increased organizational visibility into real-time PV activities.
• Organizational Growth: Scaled global PV footprints from the ground up, managing the full lifecycle of recruitment, executive-level onboarding, and succession planning for teams of 30+ specialists across international hubs.

• Risk Management & Signal Strategy: Advanced signal detection, benefit-risk analysis, and RMP/REMS oversight.
• Regulatory Diplomacy: Leading MHRA/Global Inspections and managing health authority interactions.
• Process Excellence: Six Sigma-style process optimization and CAPA/Root Cause Analysis leadership.
• Cross-functional Governance: Partnering with R&D, RA, and Marketing to align safety with business growth.

• Attended First Asia Pacific Pharmacovigilance Training course organized by WHO-UMC at JSS College of Pharmacy, Mysore, India (16-28th Feb 2015)
• Working knowledge of EMA’s Good Pharmacovigilance Practices (GVP) – Module, II, IV, V and VI
• Good Knowledge of 21 CFR Part §314.80 post-marketing reporting of adverse drug experiences; §314.81 Other Post-Marketing reports.