Shruti Dwivedi

Background

About Shruti Dwivedi

I am a results-driven healthcare professional with 13+ years of experience in Pharmacovigilance, Clinical Research, and Project Management, specializing in regulatory compliance, adverse event reporting, and operational excellence. I have a proven track record of leading global projects, ensuring adherence to ICH-GCP, FDA, EMA, MHRA, and HIPAA guidelines while optimizing workflows for efficiency, quality, and compliance. Key Expertise: End-to-End Project Management – Managing clinical research and safety operations from initiation to completion, ensuring compliance with global and local regulatory frameworks. Pharmacovigilance & Patient Safety – Expertise in ICSR processing, adverse event reporting, risk assessment, and MedDRA coding. Client & Stakeholder Management – Handling client escalations, capacity planning, workflow optimization, and quality assurance to drive high-performance operations. AI-Powered Clinical Solutions – Leveraging AI and data-driven insights to enhance patient safety, RWE analytics, and healthcare outcomes. Regulatory Compliance & Quality Management – Ensuring strict adherence to GVP, ICH-GCP, HIPAA, GDPR, and internal SOPs to maintain regulatory excellence, process deviations and CAPAs. My experience allows me to practise scientific expertise with business acumen to streamline processes, improve patient outcomes and drive innovation in the Healthcare and life science industry. I am passionate about advancing pharmacovigilance and clinical research through technology, automation, and AI-driven healthcare solutions. Always open to collaborations, industry discussions, and new opportunities in the field of patient safety, RWE, and clinical AI solutions.