Manager, PV QST Contracts & Operations (Engineering)

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 Manager, Pharmacovigilance, QST, Contracts and Operations At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise will drive meaningful impact. You will be working cross functionally and cross company to advance activities and milestones. As an integral part of our team, you'll have the opportunity to shape the future of drug safety 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 incumbent manages the Global Contracts and External Affairs function within the Global PV Operations group.  Provides oversight of all contracts with external parties including SDEAs, budgets, MSAs, invoicing and payments for services provided.  Contributes to the development or revision of existing PV processes related, but which may not be limited to Quality, Standards and Training function.  The incumbent works cross-functionally as needed with key stakeholders and external Partners on pharmacovigilance related matters.  ​ 

Performance Objectives: 

• ​​Provides oversight to all Global PV contracts and external affairs with all stakeholders along with alliance management.
• Responsible for Global PV Intelligence, gap & impact assessments and escalation.
• Responsible for global contracts, MSAs, CDAs, SOWs, invoices and payments for work provided by PV vendors.
• Contributes to work performed by pharmacovigilance vendor(s).
• Participates in all process improvement initiatives within the Global PV department.
• Provides oversight of Global PV budgets for accuracy and within yearly projections.
• Participates in the development or revision of Global SOPs, work instructions, and guidance documents.
• Ensures Global inspection readiness for pharmacovigilance inspections and audits.
• Establishes and maintains effective cross – functional and cross-company team communications to advance company's quality activities and promote best practices
• Participates in Global Quality Management System within PV including compliance, best practices, and continuous process improvements as needed.
• Participates in the development in SDEAs or pharmacovigilance agreement with Taiho business partners and vendors for specific obligations for safety data exchange and reporting as needed.
• Participates in internal PV meetings (Process improvement meeting, PV Governance meetings,, etc.) based on specific topics.​ 

Education/Certification Requirements: 

• Bachelor's degree or equivalent in healthcare or technology discipline.​ 

Knowledge, Skills, and Abilities: 

• ​​Minimum of five years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment.
• Experience in managing contracts, MSAs, CDAs, invoicing, budgets, etc.
• Demonstrated knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing global pharmacovigilance.
• Experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management, etc.
• Knowledge of medical terminology and Medical Dictionary of Regulatory Activities (MedDRA).
• 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.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Expertise in the use of Electronic Document Management System (eDMS) software.
• Proficiency with Microsoft Office 

The pay range for this position at commencement of employment is expected to be between $131k to $159k 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 a sign-on bonus, restricted stock units, commissions, 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 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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