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Job Description
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 support, and execution of inspection activities using established processes and available technologies.
Support assigned GVP regulatory inspections, including inspection preparation, hosting support, response development, tracking of commitments, risk escalation, and mitigation activities in collaboration with cross‑functional stakeholders.
Support strategic quality oversight of PV suppliers, including review of Quality Agreements, participation in supplier governance activities, and escalation of identified compliance risks in partnership with PSPV.
Provide GVP compliance review and quality input to Pharmacovigilance Agreements (PVAs), ensuring alignment with applicable global GVP regulations and Takeda standards, and escalating identified gaps, risks, or ambiguities to senior GVP Compliance leadership as appropriate.
Contribute GVP quality and compliance data to the Pharmacovigilance System Master File (PSMF), supporting the accurate reflection of Takeda’s pharmacovigilance system, processes, governance, and oversight framework.
Ensure consistency between PSPV quality system documentation, PVAs, and the PSMF, identifying inconsistencies or emerging risks and supporting corrective actions to maintain regulatory alignment and inspection readiness.
Support responses to regulatory authority requests related to the PSMF and PVAs, including preparation of supporting documentation and evidence in collaboration with PSPV, R&D Quality, and Global Regulatory stakeholders.
Contribute to quality governance activities, including preparation of materials and inputs for Management Review and the Clinical & Safety Quality Council related to GVP…