Senior Manager, GVP Compliance

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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 investiga-tions, 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 anal-ysis methodologies to support effective remediation and prevention of recurrence.

• Support CAPA lifecycle management, including tracking implementation and effectiveness, moni-toring timely completion of actions related to quality events, audits, and inspections, and escalat-ing risks where appropriate.

• Support GVP inspection readiness activities, including preparation, coordination, document sup-port, and execution of inspection activities using established processes and available technolo-gies.

• Support assigned GVP regulatory inspections, including inspection preparation, hosting support, response development, tracking of commitments, risk escalation, and mitigation activities in col-laboration with cross‑functional stakeholders.

• Support strategic quality oversight of PV suppliers, including review of Quality Agreements, partic-ipation in supplier governance activities, and escalation of identified compliance risks in partner-ship with PSPV.

• Provide GVP compliance review and quality input to Pharmacovigilance Agreements (PVAs), en-suring 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 align-ment 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 compliance.

• Provide support for Global Quality internal audits and Business Alliance audits across Takeda’s pharmacovigilance system, including preparation, coordination, response support, and CAPA fol-low‑up.

Skills and qualifications

• Scientific or allied health qualification (BSc required; Master’s/PhD strongly preferred).
• Experience (5+ years) in the global pharmaceutical industry in PV and Quality and Compliance roles (3+ years).
• Strong working knowledge and understanding of pharmacovigilance regulations including ICH Pharmacovigilance Guidelines (E2 Series), EMA Good Pharmacovigilance Practices (GVP) Directives and Modules,  US Code of Federal Regulations (CFR), FAERS and Risk Evaluation and Mitigation Strategies (REMS), Japan PMDA & MHLW GVP Ordinance and Good Post‑Marketing Study Practice (GPSP) Ordinance, Health Canada, World Health Organization (WHO) global multinational framework for International Drug Monitoring and those in countries such as China (NMPA PV), India (PvPI), etc.
• Experience in supporting GVP audits and regulatory inspections, investigations and remediation.
• Strong attention to detail with a quality and compliance mindset.
• Ability to operate effectively in cross‑functional, matrixed environments.
• Solid analytical and problem‑solving skills.
• Clear written and verbal communication skills.
• Ability to manage priorities and execute under timelines.
• Professional judgment with willingness to escalate risks appropriately.
• Integrity‑driven and patient‑focused approach aligned with Takeda values.

Locations

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

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