Description

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.
• Oversee PV vendor governance.

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 meetings, etc.) based on specific topics.
• This role may supervise PV team members.
• This position may require some occasional travel.

Education/Certification Requirements:

• Bachelor's degree in healthcare related field required.  
• RN, R.Ph., or Pharm D. degree is highly preferred.

Knowledge, Skills, and Abilities:

• Minimum of 10 years' progressive experience in pharmacovigilance in a pharmaceutical, biotech or related environment.
• Minimum 7 years' experience in pharmacovigilance, drug safety, or regulatory labeling within the pharmaceutical or biotechnology industry.
• Strong experience with minimum of 5 years of PV case processing and operations.
• Past experience managing and developing direct reports.
• In-depth knowledge of MedDRA, global labeling requirements (FDA, EMA, ICH), and safety database management.
• Experience with configuration and validation of safety database reporting rules (e.g., LSMV, Argus).
• In-depth knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
• Knowledge of adverse event regulatory reporting requirements of both clinical trial and post marketing reports.
• Excellent analytical, organizational, and communication skills.

The pay range for this position at commencement of employment is expected to be between $171,700 - $202,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#Location-Princeton,NJ #Location-Pleasanton,CA #LI-Hybrid