Nishanth Shanthakumar

Background

About Nishanth Shanthakumar

With over 9 years of experience as a Safety Technology Leader in the Global Pharmacovigilance and Life Sciences industry, I specialize in driving drug safety solutions, ensuring regulatory compliance and managing end-to-end project deliveries. I work closely with clients to gather business requirements, provide PV support, and deliver high-quality, validated safety systems that enhance patient safety and product quality. Key Expertise: Automation in Pharmacovigilance & Drug Safety Systems - Designing and implementing automation solutions to simplify processes and improve operational efficiency. Software Testing & Test Management - Ensuring quality delivery with zero critical defects and meeting project timelines through strong test planning and execution. Computer System Validation (CSV)- Experienced in implementing and validating computerized systems on cloud platforms in line with industry standards. Documentation (VP, OQ, PQ, VSR and PSR etc.)- Delivering comprehensive validation documents adhering to GDP, GAMP 5, and 21 CFR Part 11 practices. Regulatory Compliance - Strong understanding of global health authority guidelines including EMA, FDA, MHRA, and Health Canada. I am passionate about leveraging technology and innovation to strengthen pharmacovigilance operations, enhance patient safety, and drive continuous improvement in drug safety systems.