Descripción
About the role- Strengthen key elements of the global Good Pharmacovigilance Practice (GVP) compliance framework by executing and maintaining a risk‑based, digitally enabled quality system that is compliant, scalable, and sustainable across Takeda’s pharmacovigilance system.- Contribute to the implementation of an integrated GVP compliance approach in close partnership with the PSPV function and the Center for Continuous Improvement for CTD and PV, supporting aligned quality oversight and effective adoption of regulatory intelligence.- Support the effectiveness of GVP investigations, audits, and inspections by applying robust root‑cause analysis, supporting CAPA execution and compliance monitoring, and contributing to global GVP inspection readiness activities.- Contribute to effective GVP quality governance by supporting monitoring and reporting of GVP compliance risks, trends, and mitigation actions through PSPV governance forums, the R&D Quality risk register, and the Clinical & Safety Quality Council.How you will contribute- Manage and support the operation of the GVP Quality Management System (QMS) by executing review, implementation, and maintenance of standards, policies, and procedures supporting GVP‑regulated activities within PSPV.- Execute core GVP quality system processes including change control, deviations and investigations, incident notification and escalation, and CAPA management, acting as a GVP compliance subject‑matter expert.- Support investigations of significant GVP quality events and deviations, applying root‑cause analysis methodologies to support effective remediation and prevention of recurrence.- Support CAPA lifecycle management, including tracking implementation and effectiveness, monitoring timely completion of actions related to quality events, audits, and inspections, and escalating risks where appropriate.- Support GVP inspection readiness activities, including preparation, coordination, document sup-port, and execution of inspectio