Sr. Manager, PV Sciences

Taiho Oncology, Inc.•Princeton, NJ

10d•Hybrid

About The Position

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 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. 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, 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 key stakeholders and resources on pharmacovigilance-related matters.

Requirements

Bachelor’s degree in health-related discipline or equivalent. RN, R.Ph., or Pharm D. degree is highly preferred.
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.
Expert knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
Extensive working knowledge of medical terminology and medical dictionary of regulatory activities (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 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.

Nice To Haves

Experience in signal detection, safety surveillance, risk mitigation and risk management a plus.
Experience directly managing people and/or leading a cross-functional team.

Responsibilities

Lead author for all pharmacovigilance aggregate reports (e.g., DSUR, PBRER, topic reports) for assigned products in alignment with Medical Surveillance Physician.
Collaborates 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.
Responsible for ensuring that routine Global Safety Management Team (GSMT) meetings are scheduled for team’s assigned products and overseeing outcomes.
Liaises with GSMT chair to facilitate communication and support for decisions resulting from the GSMT (e.g. update of RMPs, labeling, regulatory notifications).
Evaluates current processes and escalate as needed, to enhance medical surveillance and risk management process to ensure best practices.
Supports the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for team’s assigned products.
Participates in new study initiation to ensure PV requirements are met including but not limited to: safety reporting, query resolution, SAE reconciliation, un-blinding process, and safety reporting training
Reviews protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents
Maintains 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. Safety operations related questions include but not limited to: case processing; regulatory submissions, ethics committees, investigators, and other stakeholders; safety queries; collection of safety information.
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.
Collaborates with internal and external stakeholders outside of Taiho (such as Business partners).
Demonstrates 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.
Participates in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
Provides 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, as well as 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).