Siva Prasad Yenuganti

Senior Manager Pharmacovigilance Operations @Spark Therapeutics, Inc

Philadelphia, PA, US

Oversaw vendor case processing activities, reviewed compliance reports, tracked deviations, issued notes to file, and updated procedures, ensuring alignment with regulatory expectations and internal quality standards.• Developed and implemented vendor oversight plan and quality metrics and conducted regular audits and CQA and CAPA tracking, improving case quality and ensuring sustained compliance across pharmacovigilance operations.• Created and revised SOPs, work instructions, and case processing conventions, enhanced consistency and clarity across safety data management, and ensured audit readiness.• Performed signal detection activities for Luxturna, presented findings to internal teams, identified root causes, and drove vendor resolution of recurring safety data issues.• Led reconciliation, literature surveillance, and DSUR coordination for investigational products and ensured timely submissions and compliance with global safety reporting requirements.• Partnered with Clinical Quality Assurance and IT to support audit readiness, dashboard development, and deviation and CAPA management, increasing PV operational efficiency and inspection preparedness.• Liaised with vendors, cross-functional teams, and clinical partners to resolve SAE reconciliation and PQC issues. Implemented solutions that improved data accuracy and submission timeliness.• Created vendor quality metrics by identifying error-prone Argus database fields and implemented tracking process to improve data accuracy and ensure accountability in outsourced case processing.• Requested final article submissions from client prior to health authority dispatch and updated vendor case processing guidelines to ensure timely and compliant literature expedited reporting.• Designed and implemented workflow for literature search strategy and established consistent methodology for identifying relevant safety signals and supporting regulatory reporting requirements