• Manager, PV Operations

    Job Locations US-NJ-Princeton
    Requisition ID
  • Responsibilities



    Apply knowledge of and expertise in pharmacovigilance (PV) and drug safety as well as aggregate reporting and risk management documents for product surveillance program to drive the development and maintenance of a center of excellence for Pharmacovigilance Aggregate Reporting and Risk Management deliverables. Job duties include:



    • Create and provide clinical information and safety reports as required by organizational policies and regulatory agencies such as Public Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), and Suspected Unexpected Serious Adverse Reaction (SUSARs), and aggregate report tables and listings globally as well as risk management plans. Facilitate Aggregate Report production activities across Clinical Safety and Pharmacovigilance (CSPV) and other organizations.
    • Contribute to the development and maintenance of procedures and tasks related to Health Authority requests globally.
    • Develop and maintain standard templates and processes for Pharmacovigilance contributions to submission deliverables.
    • Contribute to the development and maintenance of efficient and robust procedures to drive quality, timeliness and compliance with regulations.
    • Provide technical expertise and guidance to authors and contributors of aggregate reports and risk management plans.
    • Prepare each version of the deliverable and maintain version control of the document. Request source documents from other departments. Create workflows for each of the Aggregate Safety Reports (ASRs) and Risk Management Plans (RMPs) in the document management system.
    • Ensure all activities are completed on time and meet quality standards.
    • Collaborate with team members and lead by example.
    • Interface with other functional groups, such as Regulatory Affairs, Clinical Management/Clinical Development or other business units as needed.
    • Provide regular reports to Global Head of Aggregate Reporting on project metrics, requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner.
    • Participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies and/or other projects.
    • Perform other activities as needs arise in the context of ASRs, RMPs or PV area.
    • Support ongoing Quality Assurance (QA) activities.
    • Collaborate on the drafting of user guides for document management system.
    • Collaborate on the drafting of key Standard Operating Procedures (SOPs) and Work Processes (WPs) related to ASR processes.
    • Provide ASR compliance metrics to management.
    • Demonstrate robust knowledge of case processing, project management, quality control, and Corrective and Preventative Action (CAPA) generation.


    Minimum Requirements


    • Bachelor’s degree in the life sciences or health care field such as medicine, pharmacy, or a related discipline.
    • Five (5) years of experience with global aggregate reporting in the pharmaceutical industry, two (2) years of which must include experience with Competent Authority Inspections (PV and GCP), managing vendors, working with alliance partners, and managing pharmacovigilance agreements as well as experience with pharmacovigilance platforms Argus and Documentum.
    • Extensive knowledge of United States, International Council for Harmonization (ICH), and European Union PV and GOP regulations.

    This position requires up to 20% domestic and international travel.


    Work Schedule: Monday-Friday, 8:00 a.m. – 5:00 p.m.




    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.

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