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Senior Manager, Aggregate Reports

Company: Mitsubishi Tanabe Pharma Development America Inc.
Location: Jersey City
Posted on: January 8, 2022

Job Description:

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. MTDA is rapidly expanding our operation across all functional areas to assist in the research and development of new products for the U.S. market. The Senior Manager, Aggregate Reports will function as the overall project manager for the development and finalization of assigned key safety documents such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). The individual will also maintain and manage agreement and contract updates related to drug safety vendors and support the logistical management of global safety governance escalation meetings including agenda creation with the application of good documentation practice. The Senior Manager, Aggregate Reports collaborates with internal and external stakeholders managing data information and exchange between all parties involved. The incumbent leads stakeholder meetings and troubleshoots and mitigates issues throughout the development process of each key deliverable. Responsibilities

  • Creates and maintains the DSUR, PBRER and RMP development project schedules in compliance with global procedures and assigns deliverables to key identified stakeholders.
  • Negotiates with appropriate stakeholders to ensure that DSUR, PBRER, and RMP commitments are met.
  • Works closely with the Safety Medical Writer to develop DSURs, PBRERs, and RMPs, manage their review cycles, and ensure they are finalized in time for Health Authority submission.
  • Writes certain sections of DSURs, PBRERs, and RMPs as needed.
  • Tracks activities in close collaboration with the Global Safety Team (GST), Safety Data Management (SDM), and Safety Medical Writer, ensuring the accurate inclusion of benefit-risk assessments and risk characterizations into DSURs, PBRERs, and RMPs.
  • Collaborates closely with Global Safety Team (GST) Chairpersons and Coordinators to manage and facilitate meeting logistics, documentation, and scheduling for multiple clinical safety project teams in a cross-functional environment.
  • Maintains and manages agreement and contract updates related to drug safety vendors.
  • Maintains working knowledge of company policies and assigned products as related to drug safety roles and responsibilities.
  • Maintains working knowledge of the document management system used to review and finalize key safety documents.
  • Mentors junior pharmacovigilance (PV) personnel in their functions.
  • Performs other departmental duties as assigned. Qualifications
    • Minimum BA/BS in life/health sciences or related field; advanced degree preferred
    • Minimum of 6 years of pharmaceutical industry experience in Drug Safety including case processing; at least 2 years of experience specifically in Drug Safety aggregate reports management
    • Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization
    • Excellent oral and written communications skills
    • Strong attention to detail
    • Strong analytical and problem-solving skills Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Keywords: Mitsubishi Tanabe Pharma Development America Inc., Jersey City , Senior Manager, Aggregate Reports, Executive , Jersey City, New Jersey

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