Sr. Manager, Global Labeling & PV Operations

Sr. Manager, Global Labeling & PV Operations

Princeton, NJ, USA •

Pleasanton, CA, USA

Posted Monday, December 15, 2025 at 5:00 AM

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy. We invite you to join us.

Hybrid

Employee Value Proposition:

Embark on a transformative journey with Taiho Oncology as a Senior Manager, Global Labeling and PV Operations. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and leadership will drive meaningful impact. As an integral part of our team, you'll have the opportunity to shape the future of drug safety, contribute to groundbreaking research, and advance patient care worldwide.

With competitive compensation, comprehensive benefits, and a commitment to professional development, Taiho empowers you to thrive personally and professionally. Join us in our mission to and be a part of the Taiho evolution to have your imprint based on your experience in our rapidly evolving organization.

Position Summary:

The Senior Manager, Global Labeling Innovation & PV Operations, leads the creation, maintenance, and continuous improvement of auto-labeling data sheets for use in the global safety database. This role is responsible for ensuring labeling documents (including USPI, CCDS, IB, SmPC, and others) are current, accurate, and compliant with global regulatory requirements for ICSR assessments. The position also supports PV Operations through regulatory intelligence review and the configuration and testing of safety database reporting rules.

The ideal candidate brings deep expertise in PV case processing and operational excellence.

Performance Objectives:

Labeling (50%)

• Develop, update, and maintain auto-labeling data sheets for the safety database, ensuring alignment with regulatory requirements and internal procedures.
• Collaborate with PV Scientists and PV Medical Surveillance Physicians to manage and update auto-labeling data sheets with annual IB update.
• Ensure labeling documents such as USPI, CCDS, Investigator’s Brochure (IB), SmPC, and other global product labels are current for the assessment of ICsRs.
• Coordinate with relevant stakeholders to incorporate MedDRA updates into labeling data sheets.
• Serve as the subject matter expert for labeling processes, providing guidance and training to cross-functional teams.

PV Operations & PV Regulatory Intelligence (25%)

• Review and evaluate regulatory intelligence updates impacting PV operations globally, ensuring timely impact assessment.
• Collaborate with relevant stakeholders to operationalize new or revised regulations and guidance.
• Oversight of vendor reconciliation process and other outsourced PV activities.

Safety Database Reporting Rules (25%)

• Coordinate with PV safety database administrators to configure, test, and validate reporting rules in the safety database, ensuring compliance with global and local reporting requirements.
• Investigate and resolve issues related to reporting rules and case distribution.

Other Responsibilities

• Contributes to inspection readiness and supports Health Authority inspections of Taiho’s pharmacovigilance function.
• Participates in internal PV meetings (Process improvement meetings, safety database team…