Taiho Oncology

  • Sr. Scientist, PV Sciences

    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 works with the PV physician(s) on all aspects of medical surveillance and risk management activities for assigned investigational and marketed products.  Works cross-functionally with internal and external key stakeholders, Clinical, Regulatory, Medical Affairs and external resources on pharmacovigilance-related matters.  Typically assigned work of a more complex nature and scope.

    Responsibilities

    • Working with PV physicians, supports medical surveillance and risk management activities for assigned products or therapeutic area.
    • Provides project management; compiles and authors pharmacovigilance aggregate reports (e.g. DSUR, PBRER, topic reports) for assigned products.
    • Collaborates with PV physicians and key stakeholders to request/receive applicable sections of the report.
    • Ensures timely submission to relevant health authorities and other external stakeholders.
    • Provides safety information as needed for study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling for assigned products.
    • Collaborates with the PV physicians to ensure all information is available to allow for informed medical review and benefit-risk assessment of assigned products.
    • Working with PV physicians, contributes to safety surveillance and signal detection activities for assigned products or therapeutic area.
    • Ensures that routine Global Safety Product Committee (GSPC) meetings are in place for assigned products and shares best practices.
      • Schedules and coordinates meetings.
      • Ensures appropriate stakeholder representation and input per GSPC SOP.
      • Liaises with GSPC chair to facilitate communication and support for decisions resulting from the GSPC (e.g. update of RMPs, labeling, regulatory notifications).
    • Supports the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for assigned products.
      • Responsible for ensuring that all RMP commitments are efficiently tracked.
      • Responsible for working with external stakeholders to update the RMP as needed.
      • Leads internal PV meetings (Product Meeting, Process improvement meeting, etc.) based on assigned products.
      • Collaborates with internal and external stakeholders outside of PV and represents PV department in cross-functional meetings and additional activities to support assigned clinical developmental programs.
      • Maintains a thorough understanding of all clinical and post-marketing activities and PV requirements for assigned products.
      • Participates in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
      • 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.
      • Provides expertise by guiding, training, and overseeing pharmacovigilance vendor supporting pharmacovigilance activities.
      • May provide training and mentorship to PV Scientists.

    Qualifications

    • 4 to 7 years’ experience in Pharmacovigilance environment and with a minimum of 2 years’ experience in a PV Scientist role managing adverse events processing on a global basis.
    • Knowledge of ICH/FDA guidelines for GCP and Clinical Safety Reporting.  
    • Extensive working knowledge of medical dictionary of regulatory activities (MedDRA). 
    • Experience with the use of global safety databases is required.
    • Experience leading safety data review meetings, creating agenda and meeting minutes.
    • Experience leading SAE reconciliations.

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