Taiho Oncology

  • Manager, PV QST Contracts & Operations

    Job Locations US-NJ-Princeton
    Category
    Pharmacovigilance
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy. The incumbent manages the Contracts and External Affairs function within the Quality, Standards and Training (QST).    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.  

    Responsibilities

    • Provides oversight to all PV contracts and external affairs with all stakeholders.
    • Responsible for Global PV Intelligence, gap & impact assessments and escalation.
    • Responsible for 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 PV department.
    • Provides oversight of PV budgets for accuracy and within yearly projections.
    • Participates in the development or revision of SOPs, work instructions, and guidance documents.
    • Ensures GPV readiness for pharmacovigilance inspections and audits.
    • Establishes and maintains effective cross - functional team communications to advance company’s quality activities and promote best practices
    • Participates in 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 TOI business partners and vendors for specific obligations for safety data exchange and reporting as needed.
    • Participates in internal PV meetings (Process improvement meeting, safety database team meetings, etc.) based on specific topics.

    Qualifications

    • Bachelor’s degree or equivalent in healthcare or technology discipline.
    • Minimum of 4 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 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).

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