Taiho Oncology

  • Director, PV DM & Processing

    Job Locations US-NJ-Princeton
    Category
    Pharmacovigilance
    Travel
    10%
    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 is accountable for setting up the future direction and strategy for PV safety database and its functionality within the Pharmacovigilance department. This includes all aspects of safety database management, including but not limited, to case processing or oversight, electronic submissions, database configuration including Health Authority reporting matrix, and safety database version upgrades (ARISg, Argus, or AI embraced safety database platform).

     

    Responsibilities

    Responsibilities and Duties: 

    • Develops and oversees safety database and other electronic databases used for pharmacovigilance.
    • Responsible for oversight of all case processing, workflow management, and quality control of work performed internally or by PV vendor.
    • Functions as the safety database administrator for the Pharmacovigilance department.
      • Ensures the safety database is in validated state.
      • Ensures system configurations and library registrations are up to date per regulations and business needs.
      • Leads the configuration and validation of safety system updates and upgrades.
      • Oversees E2B testing with required Health Authorities to obtain certificates.
    • Oversees the development of safety system training materials and delivers training to both employees and PV vendors.
    • Provides oversight on supporting all necessary listings for aggregate reports, signal detection, monthly safety data review, GSPC, etc.
    • Responsible for the safety data management activities and all information systems owned by Pharmacovigilance department.
    • Provides expertise in the areas of safety systems, global pharmacovigilance regulations, and industry practices to effectively solve challenges and facilitate meaningful technology-enabled process solutions.
    • Drives business integration including safety data migration and integrating new assets or companies into Taiho PV system.
    • Provides oversight to all safety data submissions and exchanges with Health Authority and TOI business partners.
    • Contributes to new or revision of SOPs, work instructions, guidance in regards to all functions within PV.
    • Contributes to PV Quality Management System including compliance, best practices, and continuous process improvements.
    • Builds relationships, and collaborates with, Regulatory Affairs Operations to improve process for safety reporting to global Health Authorities.
    • Responsible for inspection readiness of pharmacovigilance safety database.
    • Establishes good communication and fosters relationships with all stakeholders including TPC, PV Vendors, and Taiho Partners on all pharmacovigilance related issues.
    • Leads internal PV meetings (Process improvement meeting, safety database team meetings, etc.) based on specific topics.

    Qualifications

    Educational Requirements:   

    • Bachelor’s degree or equivalent in healthcare or technology related discipline.

    Experience: 

    • Minimum of 8 years of progressive experience working with safety databases and electronic solutions in a pharmacovigilance department, with at least 4 of which were spent in a leadership/management role within pharmacovigilance. 
    • Demonstrated working knowledge of the clinical trial setting.
    • Experience in signal detection, safety surveillance, risk mitigation and risk management a plus.
    • Experience directly managing people and or leading a cross-functional team.
    • Expert 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, etc.
    • Extensive working knowledge of safety databases and other electronic tools used in pharmacovigilance arena.

    Other Skills and Abilities:

    • Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
    • 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.

    Language Skills:

    • Highly developed skills in verbal and written communication, planning, and organization.

    Reasoning Ability:

    • Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.

    Computer Skills:

    • Experience with the use of global safety databases is a plus. 
    • Expertise in the use of Electronic Document Management System (eDMS) software.
    • Experience with Pharmacovigilance management tracking tools.
    • Excellent PC skills including MS Office products (Word, Excel, and PowerPoint).

    Physical Demands: 

    • While performing the duties of this job, the employee is regularly required to sit.
    • The employee is frequently required to talk and hear.
    • The employee is occasionally required to walk.

    Work Environment: 

    • The noise level in the work environment is usually quiet.
    • Must be able to travel domestically and internationally approx. 0-10% of time including some weekend travel.

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    The incumbent in this position may be required to perform other duties, as assigned.

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