Associate Director, PV Sciences - Taiho Oncology

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 an Associate Director 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 Associate Director, 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 in collaboration with the Medical Surveillance Physician. The incumbent is expected to work cross-functionally with key internal and external key leaders and external resources on pharmacovigilance-related matters.

Performance Objectives:

• Lead aggregate reports (e.g. DSUR, PBRER, topic reports) for assigned products.
• Responsible for supporting Medical Surveillance Physicians towards product benefit-risk assessment and related activities of assigned product/s.
• Responsible for collaborating with Medical Surveillance Physicians towards adhoc and routine Global Safety Management Team (GSMT) meetings.
• Lead signal management activities in collaboration with the Medical Surveillance team.
• Lead development/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 but not limited to- safety reporting, query resolution, SAE reconciliation, un-blinding process, and safety reporting training.
• Participate in the review of protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials.
• Evaluate current processes and escalate as needed, to enhance medical surveillance and risk management process towards continuous improvement and to ensure best practices.
• 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).
• Effectively manage to ensure compliance with regulatory submissions and internal timelines.
• Participate in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
• Maintain training and oversight to clinical operations/pharmacovigilance vendors supporting pharmacovigilance activities, as needed.
• 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 health-care related discipline or equivalent.  RN, R.Ph., or Pharm D. degree is highly preferred.
• Minimum of 6-8 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment,
• Proficiency in signal detection, safety surveillance, risk mitigation and risk management.
• Experience directly managing people and/or leading a cross-functional team is a plus.
• Expertise in 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.

Knowledge, Skills, and Abilities:

• 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.

The pay range for this position at commencement of employment is expected to be between $181,050 – $213,000 annually; 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 a sign-on bonus, 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 PTO, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an 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.

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