• Senior Associate PV Operations (Global Case Processing)

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10442
  • Responsibilities

    This position will be responsible for the collection, documentation and processing immediately reportable events from clinical trials and all adverse events from post marketing spontaneous reports in accordance with Global Pharmacovigilance Regulations and the company's Standard Operating Procedure. Closely Monitor the safety profile of assigned products, both in development and post-marketing.  Actively contributes to the preparation of aggregate and ad hoc safety reports. The position also includes but is not limited too:

    • Maintains accurate and complete knowledge of all investigational and marketed products being monitored by Otsuka, co-marketers, co-sponsors, and/or affiliates.
    • Collects, documents, and processes adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance.  This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check
    • Initiates follow-up calls to investigative sites and spontaneous reporters, as needed, to retrieve missing AE information, according to SAE reporting requirements, regulatory guidelines, and department SOPs.
    • Conducts periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision
    • Maintains a thorough understanding of internal and external interactions, and scope of work assigned to the department
    • Assists with conducting literature searches for assigned products
    • Drafts safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports
    • Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks
    • Serves as resource for CS & PV Associates and Assistants
    • Maintains effective working relationships with Investigational study site staff
    • Provides training on the technical and operational aspects of programs to CS & PV team members (and other OPDC staff as appropriate).
    • Communicates product safety issues to team members in a timely manner.
    • Utilizes regulatory and GCP knowledge to assist team members in the assessment of adverse event reports
    • Represents CS & PV at interdepartmental team meetings
    • Represents CS & PV at meetings conducted with licensing partners, agents, CROs, and clinical site investigators
    • Interact on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues
    • Reviews and provides input on protocols, case report forms, investigator brochures, package inserts, and NDA/PLA documents
    • Contributes to presentations, discussions, and data summaries on safety issues at meetings with external groups such as licensing partners, agents, contract research organizations, independent safety monitoring committees, and clinical site investigators

     

    Qualifications

    Required:

    Knowledge

    • Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial and post-marketing environments desirable
    • Requires a solid understanding of medical and clinical practices, with a strong understanding of medical concepts and terminology
    • Working knowledge of MedDRA dictionary with relevance to adverse event coding

     Skills

    • Strong computer skills with demonstrated experience in working with the Microsoft Office (Word, Excel, PowerPoint, and Outlook).
    • Knows how/when to apply organizational policy or procedures to a variety of situations
    • Excellent verbal and written communication skills
    • Time management skills

    Education and Related Experience

    RN, LPN, or Pharmacist with 3 years or more of drug safety experience AND additional clinical or pharmaceutical experience

    OR

    BS with 5 years or more of drug safety 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/.

    Disclaimer

    Disclaimer:

    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.


    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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