Pharmacovigilance Specialist

A highly skilled pharmacovigilance professional with proven leadership in PV operations across CTIMPs, and device trials. Proven expertise in safety assessment activities, benefit-risk management, and clinical safety signal detection across a diverse portfolio of therapeutic areas, including Cancer. Demonstrated success in PV quality management systems, strategic oversight of safety operations, and preparation of high-quality regulatory submissions, including PSURs, DSURs, and RMPs. An effective communicator adept at cross-functional collaboration, clinical safety risk communication, and ensuring compliance with global regulatory standards. Excels in leadership, adaptability, and strategic decision-making, with a passion for advancing patient safety and driving innovation in pharmacovigilance processes. Expertise includes DSUR and SUSAR submissions, MedDRA coding, SOP development, and safety database oversight. Skilled at internal audits, stakeholder engagement, and aligning PV systems with GCP/GVP standards to support clinical trial safety across complex portfolios.