Senior Manager, GVP Compliance

About the role

Takeda is looking for a Senior Manager, GVP Compliance in Zurich to strengthen its global Good Pharmacovigilance Practice (GVP) compliance framework. The role runs a risk-based, digitally enabled quality system that is compliant, scalable and sustainable across the pharmacovigilance system, working closely with the PSPV function and the Center for Continuous Improvement for CTD and PV.

Key responsibilities

• Manage and support the GVP Quality Management System (QMS), including standards, policies and procedures, and core processes such as change control, deviations and investigations, incident notification, escalation and CAPA management.
• Support investigations of significant GVP quality events and deviations, and support CAPA lifecycle management, including tracking implementation and effectiveness.
• Support GVP inspection readiness and support assigned GVP regulatory inspections, including preparation, hosting support, response development and risk escalation.
• Oversee quality oversight of PV suppliers, including review of Quality Agreements and escalation of compliance risks.
• Review Pharmacovigilance Agreements (PVAs) against global GVP regulations and Takeda standards, and contribute GVP quality and compliance data to the Pharmacovigilance System Master File (PSMF).
• Ensure consistency between PSPV documentation, PVAs and the PSMF, and respond to regulatory authority requests on the PSMF and PVAs.
• Contribute to quality governance, including Management Review and the Clinical & Safety Quality Council, and support Global Quality and Business Alliance audits.

Required profile

• BSc in science or allied health (Master's/PhD strongly preferred).
• 5+ years in the global pharmaceutical industry in PV and Quality and Compliance roles (3+ years).
• Experience supporting GVP audits, regulatory inspections, investigations and remediation.
• Ability to work in cross-functional, matrixed environments and to manage priorities under tight deadlines.

Required skills

• Strong knowledge of pharmacovigilance regulations: ICH E2 series, EMA GVP directives and modules, US CFR, FAERS and REMS, Japan PMDA and WHO frameworks, and others such as China and India.
• Attention to detail, analytical and problem-solving skills, clear written and verbal communication, and integrity-driven, patient-focused approach.

The position is full time and regular, with a base salary range of CHF 141,100 to CHF 194,040 depending on qualifications, experience and location.