Senior Pharmacovigilance Manager with 15+ years of expertise in global drug safety, and 2 years of specialized experience in medical device vigilance and complaint management. Proven track record of leading 100+ FTE global teams, delivering high-quality ICSR management, and regulatory submissions. Skilled in audit and inspection readiness, CAPA development, and regulatory compliance with ICH-GVP, EU MDR, FDA 21 CFR Part 803, and ISO 13485. Adept at implementing and validating PV systems (ARISg, LSMV), driving operational efficiencies, and building inspection-ready, high-performing teams. Recognized for fostering cross-functional collaboration.