• Submissions Specialist Global PV Operations

    Job Locations US-NJ-Princeton
    Requisition ID
  • Responsibilities

    The Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Submission specialist will perform the reconciliation of submission dates and assist with site audit requests. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

    As a member of the Drug Safety and Pharmacovigilance department, the Global PV Workflow Sr. Associate is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations. The Global PV Workflow Sr. Associate will ensure the uniform and timely processing and reporting of adverse events to regulatory authorities and business partners in collaboration with Drug Safety Operations team members. Global PV Workflow Sr. Associate will participate in the set-up and development of monitoring tools and maintenance of adverse event workflows within Avisso to meet global regulatory reporting requirements. In addition, the Global PV Workflow Sr. Associate will assist with the case readiness for internal and external reports (PSURs, PADERs, etc.). The Global PV Workflow Sr. Associate, will coordinate and monitor the department’s workflow, and assist in special projects as assigned. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting. 


      • Coordinate Safety Operations workflow to ensure timely processing and reporting of adverse events to regulatory authorities and business partners
      • Generate and use established reports to monitor daily case workload and reports due, working with team members to identify potential bottle necks or resource gaps and coordinate work plans accordingly
      • Generate and use established reports to monitor action items, reports worklist and additional worklist as needed.
      • Participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures
      • Assist in the ensuring ICSR readiness for inclusion in individual and aggregate reports (PSURs, PADERs, etc.) 
      • Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports
      • Review adverse event information received for completeness and consistency, initiate case follow-up activities/AE query management, and independently generate narratives in accordance with department processes
      • May perform quality control activities to ensure complete and accurate case information has been entered into the drug safety database
      • Follow company processes and guidelines for case management and closure activities, and adhere to company templates and guidelines for documentation and communications
      • Ensure compliance with corporate and departmental standard operating procedures Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within PV Operations.
    • May assist in the preparation of ICSR health authority responses


    • May manage department staff
    • May distribute completed regulatory reports
    • May provide support and back-up to the submission function
    • Perform other activities as directed by Drug Safety and Pharmacovigilance management
      • 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
      • Provides training on the technical and operational aspects of programs to GPV 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 GPV at interdepartmental team meetings
      • Represents GPV at meetings conducted with licensing partners, agents, CROs, and clinical site investigators
      • Interacts 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





    • Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
    • Knowledge of the ARGUS Safety Database
    • Knowledge and prior experience in case processing*
    • Knowledge of the interworking’s of Global Pharmacovigilance organization is desired
    • Experience with managing vendors, partners, and/or CRO's preferred 


    • Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
    • Strong communication and writing skills.
    • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
    • Knows how/when to apply organizational policy or regulatory procedures to a variety of situations.
    • Ability to work under pressure in order to meet tight timelines
    • Able to work effectively in a matrix environment
    • Strong attention to detail along with the ability to problem solve
    • The ability to provide direction to a team, and to influence peers and team members appropriately preferred
    • Excellent project management skills with the ability to align internal and external resources
    • Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations

    Education and Related Experience

    • Degree preferred to be in Bachelors of Science or related healthcare degree however may be waived for relevant experience**
    • Minimum of 4 years drug safety experience required
    • Demonstrated proficiency in safety database functionality
    • Global Drug Safety Case processing experience*

    *Safety experience is defined as actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

    **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance


    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 

    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.


    Come discover more about Otsuka and our benefit offerings; click here for more information




    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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