• Associate PV Operations (Global Case Processing)

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10204
  • Responsibilities

    Enters spontaneous post-marketing adverse event (AE) data and immediately reportable events from clinical trials into the safety database. Provides support to Clinical Safety Associates for project-specific administrative tasks, including electronic and hard copy records management, data entry activities, and metrics collection. Takes accountability for the accuracy of AE data entry information.

     

      • Responsible for processing incoming AE information, including:
        • Performs triage and assigns priority to time sensitive and project critical incoming events and classifies them according to regulatory reporting criteria.
        • Confirms presence of adequate patient, medical and adverse event information needed to perform case evaluation.
        • Reviews clinical study adverse events for accuracy, integrity, and consistency according to project-specific guidelines.
        • Performs electronic or manual preliminary adverse event coding, as necessary, and in accordance with Standard Operating Procedures.
        • Reviews relevant source documents for consistency and verification of adverse event data.
        • Prepares drug safety narratives, according to approved template.
        • Interacts with CS&PV team members to ensure correct and timely adverse event processing.
        • Adheres to required timelines for completion of adverse event report.
        • Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
        • Routing report information to appropriate Clinical Safety and Pharmacovigilance (CSPV) personnel for continued AE case processing.
        • Assisting in generation of database queries for AE listings. Documentation of outgoing AE information, including:
        • Preparing reports as directed by Clinical Safety & Pharmacovigilance.
        • Generating predetermined safety data reports.
        • Performing QC activity as directed by CSPV managers.
        • Transmitting/distributing reports.
        • Assisting in tracking and confirmation of report destination.
        •  
    • Maintaining adequate records, including:
    • Assisting in follow-up tracking as mandated by SOP014.
    • Assisting in records location and retrieval
      • Assisting in Document Control Room file maintenance according to company and CSPV policy.
      • Assisting in the creation of entry specifications, report specifications, and database mapping documents as directed by CSPV associate.
      •  
      • Supports clinical projects, including:
      • Maintaining up-to-date knowledge of protocol and scope of work for assigned projects.
      • Communicating monthly adverse event report totals, product safety issues, and concerns to CSPV management.
      • Identifying and communicating data entry issues to CSPV management in a timely manner.
      • Providing process improvement suggestions.
      • Managing the preparation and posting of monthly reports to the Clinical Teams and CSPV Web site.
      • Ensuring the safety database is maintained as necessary to track documentation.
      • Tracking critical document submission dates (e.g., 15-day safety reports) as a time management tool for department.
      Organizing and maintaining an inventory of safety reports for use by department. .

    Qualifications

    Knowledge     

      • Requires knowledge of standard query language and knowledge of industry terminology.
      • Familiarity with drug safety databases
      • Skills
      •  
      • Ability to use software applications to track databases.
      • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
    • Excellent command of written and spoken English

     

    • Competencies
    • Proven ability to work in a team environment

     

    Education and Related Experience

    • Bachelor degree in a scientific field, preferably in the health sciences area (e.g., Nursing, Pharmacy)
    • 2 years of data entry experience in the pharmaceutical industry.

    Overview

    Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.   

     

    OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

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