What are the responsibilities and job description for the Sr. Manager, Global Labeling & PV Operations position at Lensa?
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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%)
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
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
Job Details
Job Family R&D
Job Function Pharmacovigilance
If you have questions about this posting, please contact support@lensa.com
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.
- 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.
- 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.
- 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.
- Bachelor’s degree in healthcare related field required.
- RN, R.Ph., or Pharm D. degree is highly preferred.
- 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.
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
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
Job Details
Job Family R&D
Job Function Pharmacovigilance
If you have questions about this posting, please contact support@lensa.com
Salary : $171,700 - $202,000