Taiho Oncology, Inc.
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Sr. Manager, PV Sciences
role at
Taiho Oncology, Inc.
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 Embark on a transformative journey with Taiho Oncology as a Senior Manager in PV Sciences. 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.
Position Summary The Senior Manager, PV Sciences role will support medical surveillance activities and maintain oversight for the Pharmacovigilance Sciences function within the PV department. This includes managing all PV activities for assigned products. The incumbent is expected to work cross‑functionally with key internal and external stakeholders on pharmacovigilance‑related matters.
Performance Objectives
Lead author for all pharmacovigilance aggregate reports (e.g., DSUR, PBRER, topic reports) for assigned products in alignment with Medical Surveillance Physician.
Collaborate with Medical Surveillance physicians to ensure all information is available to allow for informed medical review and benefit‑risk assessment of team’s assigned product(s).
Responsible for signal detection activities in collaboration with the Medical Surveillance physicians, such as monthly signal detection, GSMT and other reviews.
Ensure that routine Global Safety Management Team (GSMT) meetings are scheduled for team’s assigned products and oversee outcomes.
Liaise with GSMT chair to facilitate communication and support for decisions resulting from the GSMT (e.g., update of RMPs, labeling, regulatory notifications).
Evaluate current processes and elevate as needed, to enhance medical surveillance and risk management processes to ensure best practices.
Support the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for team’s assigned products.
Participate in new study initiation to ensure PV requirements are met including safety reporting, query resolution, SAE reconciliation, un‑blinding process, and safety reporting training.
Review protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summaries of the NDA/MAA and product labeling and other applicable documents.
Maintain oversight of vendor performing PV activities for team’s assigned product(s).
Provide guidance on questions around safety operations based on company conventions, aligned with ICH and regulatory guidance.
Oversee and manage review and approval of the Safety Reporting Plans, as applicable.
Develop or update Standard Operating Procedures, Working Instructions, and training materials for applicable tasks as needed.
Collaborate with internal and external stakeholders outside of Taiho (such as Business partners).
Demonstrate understanding of all clinical and post‑marketing activities and PV requirements for assigned products.
Effectively manage to ensure compliance with regulatory submissions and internal timelines.
Participate in audit preparedness activities and serve as subject‑matter expert during regulatory inspections in collaboration with team members.
Provide training and oversight to pharmacovigilance vendor supporting pharmacovigilance activities, as needed.
Assist in performing investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non‑compliance issues and findings, and assess the effectiveness of the CAPAs.
Other supporting activities on behalf of PV Sciences, as needed or as requested by supervisor.
This role may have direct reports (other PV Scientists, or consultants, as applicable).
Education / Certification Requirements
Bachelor’s degree in a health‑related discipline or equivalent. RN, R.Ph., or Pharm D. degree is highly preferred.
Knowledge, Skills, and Abilities
Minimum of 5 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership/managerial role within pharmacovigilance sciences.
Experience in signal detection, safety surveillance, risk mitigation and risk management is a plus.
Experience directly managing people and/or leading a cross‑functional team.
Expert knowledge of FDA, EU and ICH guidelines, initiatives, and regulations governing pharmacovigilance.
Extensive working knowledge of medical terminology and MedDRA. Demonstrated hands‑on experience identifying, developing, and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
Excellent verbal and written communication and writing skills.
Ability to work independently and collaboratively, as required, in a fast‑paced matrixed team environment consisting of internal and external team members.
Excellent planning, organization and time‑management skills, including the ability to support and prioritize multiple projects.
Ability to influence without direct authority.
Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
Ability to write reports, business correspondence, and procedures.
Ability to effectively present information and respond to questions from internal and external clients, both domestic and international.
Ability to work with mathematical concepts such as probability and statistical inference.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical thinker with excellent problem‑solving skills and the ability to adapt to changing priorities and deadlines.
Compensation and Benefits 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. Base pay offered may vary depending on individual factors, including market location, job‑related knowledge, skills and experience. The total compensation package may also include other elements such as annual bonus/incentive plans, potential long‑term incentive plans, and discretionary awards in addition to a full range of medical, financial and other benefits (including 401(k) eligibility, and paid time off such as vacation, sick time, and parental leave). Details of participation in these benefit plans will be provided when an offer is made.
Equal Opportunity Employer Statement 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 under federal, state or local law. If you have a disability, need an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com.
Locations
Princeton, NJ
Pleasanton, CA
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Other (Pharmaceutical Manufacturing)
Additional Notes The incumbent in this position may be required to perform other duties as assigned.
Contact People@taihooncology.com
#J-18808-Ljbffr
Sr. Manager, PV Sciences
role at
Taiho Oncology, Inc.
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 Embark on a transformative journey with Taiho Oncology as a Senior Manager in PV Sciences. 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.
Position Summary The Senior Manager, PV Sciences role will support medical surveillance activities and maintain oversight for the Pharmacovigilance Sciences function within the PV department. This includes managing all PV activities for assigned products. The incumbent is expected to work cross‑functionally with key internal and external stakeholders on pharmacovigilance‑related matters.
Performance Objectives
Lead author for all pharmacovigilance aggregate reports (e.g., DSUR, PBRER, topic reports) for assigned products in alignment with Medical Surveillance Physician.
Collaborate with Medical Surveillance physicians to ensure all information is available to allow for informed medical review and benefit‑risk assessment of team’s assigned product(s).
Responsible for signal detection activities in collaboration with the Medical Surveillance physicians, such as monthly signal detection, GSMT and other reviews.
Ensure that routine Global Safety Management Team (GSMT) meetings are scheduled for team’s assigned products and oversee outcomes.
Liaise with GSMT chair to facilitate communication and support for decisions resulting from the GSMT (e.g., update of RMPs, labeling, regulatory notifications).
Evaluate current processes and elevate as needed, to enhance medical surveillance and risk management processes to ensure best practices.
Support the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for team’s assigned products.
Participate in new study initiation to ensure PV requirements are met including safety reporting, query resolution, SAE reconciliation, un‑blinding process, and safety reporting training.
Review protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summaries of the NDA/MAA and product labeling and other applicable documents.
Maintain oversight of vendor performing PV activities for team’s assigned product(s).
Provide guidance on questions around safety operations based on company conventions, aligned with ICH and regulatory guidance.
Oversee and manage review and approval of the Safety Reporting Plans, as applicable.
Develop or update Standard Operating Procedures, Working Instructions, and training materials for applicable tasks as needed.
Collaborate with internal and external stakeholders outside of Taiho (such as Business partners).
Demonstrate understanding of all clinical and post‑marketing activities and PV requirements for assigned products.
Effectively manage to ensure compliance with regulatory submissions and internal timelines.
Participate in audit preparedness activities and serve as subject‑matter expert during regulatory inspections in collaboration with team members.
Provide training and oversight to pharmacovigilance vendor supporting pharmacovigilance activities, as needed.
Assist in performing investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non‑compliance issues and findings, and assess the effectiveness of the CAPAs.
Other supporting activities on behalf of PV Sciences, as needed or as requested by supervisor.
This role may have direct reports (other PV Scientists, or consultants, as applicable).
Education / Certification Requirements
Bachelor’s degree in a health‑related discipline or equivalent. RN, R.Ph., or Pharm D. degree is highly preferred.
Knowledge, Skills, and Abilities
Minimum of 5 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership/managerial role within pharmacovigilance sciences.
Experience in signal detection, safety surveillance, risk mitigation and risk management is a plus.
Experience directly managing people and/or leading a cross‑functional team.
Expert knowledge of FDA, EU and ICH guidelines, initiatives, and regulations governing pharmacovigilance.
Extensive working knowledge of medical terminology and MedDRA. Demonstrated hands‑on experience identifying, developing, and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
Excellent verbal and written communication and writing skills.
Ability to work independently and collaboratively, as required, in a fast‑paced matrixed team environment consisting of internal and external team members.
Excellent planning, organization and time‑management skills, including the ability to support and prioritize multiple projects.
Ability to influence without direct authority.
Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
Ability to write reports, business correspondence, and procedures.
Ability to effectively present information and respond to questions from internal and external clients, both domestic and international.
Ability to work with mathematical concepts such as probability and statistical inference.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical thinker with excellent problem‑solving skills and the ability to adapt to changing priorities and deadlines.
Compensation and Benefits 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. Base pay offered may vary depending on individual factors, including market location, job‑related knowledge, skills and experience. The total compensation package may also include other elements such as annual bonus/incentive plans, potential long‑term incentive plans, and discretionary awards in addition to a full range of medical, financial and other benefits (including 401(k) eligibility, and paid time off such as vacation, sick time, and parental leave). Details of participation in these benefit plans will be provided when an offer is made.
Equal Opportunity Employer Statement 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 under federal, state or local law. If you have a disability, need an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com.
Locations
Princeton, NJ
Pleasanton, CA
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Other (Pharmaceutical Manufacturing)
Additional Notes The incumbent in this position may be required to perform other duties as assigned.
Contact People@taihooncology.com
#J-18808-Ljbffr