Krishna Swaroop K

Experienced Pharmacovigilance professional with over 11 years of expertise in drug safety, risk management, and global regulatory compliance. Proven ability to lead cross-functional PV teams, implement end-to-end safety strategies, and manage complex safety database migrations. Adept at aligning operations with EMA, FDA, ICH, and Health Canada guidelines, driving regulatory excellence and quality compliance.

I hereby declare that the information provided is true and correct to the best of my knowledge and belief.

• Annual Star Performer and Go-getter award – Biocon
• Best Performer & Quality Champion Awards – GSK.
• Performance linked Aware (PLR) as Best performer - TCS.
• Quality champion and BPS performance league - TCS.

• Safety Database Migration, 02/2024, Spearheaded the complete migration from ARISg to Argus safety database system. The project involved extensive planning, system validation, stakeholder training, and ensuring compliance with 21 CFR Part 11 and GDPR. Successfully managed data integrity for 100,000+ safety reports while maintaining business continuity across global PV operations.
• Global PV Framework Development, Conceptualized and developed a robust pharmacovigilance governance model tailored to meet EU MDR and FDA 21 CFR requirements. Created PV procedures from ground up, authored SOPs, and introduced risk-based monitoring. The framework is currently operational across three international regions.
• Vendor Management & Optimization, Directed oversight global pharmacovigilance vendors. Instituted a vendor performance tracking system and SLAs, resulting in a 40% improvement in on-time deliverables. Conducted quarterly performance reviews and initiated compliance training programs for external teams.
• Regulatory Inspection Excellence, 01/2023, Led end-to-end inspection readiness for EMA and local regulatory authorities. Designed and executed audit response protocols, managed CAPA implementation, and achieved a “zero findings” outcome in the 2023 EMA inspection. Recognized with the Annual Star Performer award for outstanding audit leadership.
• Organizational Transition Support, Played a pivotal role in the merger and bifurcation of PV entities post-corporate restructuring. Defined PV roles and responsibilities for the new entities, updated safety data exchange agreements (SDEAs), and coordinated system changes to reflect structural updates.