ZOLL Circulation, Inc.

  • Medical Safety Monitor

    Job Locations US-CA-San Jose
    Posted Date 5 months ago(2/8/2018 2:09 PM)
    Job ID
    # of Openings
    Customer Service/Support
  • Overview

    General Summary:


    This position will ensure medical safety data review and evaluation in accordance with post-market and pre-market regulatory requirements. Communicates potential and known risks, when appropriate, to Management, Quality Assurance, Regulatory Affairs, and Clinical Affairs personnel. Conduct clinical trial safety and commercial safety activities.


    Essential Functions:

    • Provides medical safety expertise to the Quality Assurance, Regulatory Affairs, and Clinical Affairs teams and programs.
    • Provides safety review to post-market complaints and pre-market clinical trial events and complete appropriate documentation.
    • Performs CEC process including source documents and narratives review and handling
    • Manages vendors responsible for safety services including Clinical Event Committee, Date Monitoring Committee, Imaging Service, etc.
    • Provides medical input into the clinical trials documents and training materials.
    • Provides training on safety matters to personnel in relevant departments.
    • Collaborates with cross functional teams on activities related to managing the safety of products.
    • Presents post-market and clinical safety and risk management evaluations as necessary to Senior Management Team.
    • Participates in post-market and pre-market clinical safety and risk management programs.
    • Provides input and review to regulatory or clinical documents as appropriate, to ensure these key safety documents are of high safety and scientific quality.
    • Supports operational tasks in Medical Affairs department.


    Skill Requirements:


    • Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc.) and present the findings clearly in both written and oral communications.
    • Experience and knowledge of Good Clinical Practices in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings and risk management plans.
    • Able to plan work to meet deadlines and effectively handle multiple priorities.
    • Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable.
    • Ability to influence, negotiate and communicate with both internal and external customers.
    • Working knowledge of the use of Microsoft suite of software products including Excel and Word. Proficiency in PowerPoint is desired.

    Education/Training/Experience Requirements:

    • Physician with Board Certification (if US) or Medical Degree holder from a recognized Medical School (if OUS) with 4-5 years related medical clinical experience.
    • Experience in clinical safety, clinical research, and vigilance.
    • Demonstrated in-depth knowledge of principles of clinical trial methodology and design, medical monitoring of trials, assessment of medical device risks and benefits, and safety assessment of medical devices both on the market and in development and global safety regulations.


    Language Ability:

    Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively in front of the groups of customers or employees of organization.


    Math Ability:

    Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.


    Reasoning Ability:

    Ability to apply common sense understanding to carry out detailed written or oral instructions. Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.


    Computer Skills:

    Basic computer skills are required.


    Certificates and Licenses:

    No certifications needed


    Supervisory Responsibilities:

    This job has no supervisory responsibilities.


    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.


    The noise level in the work environment is usually moderate. The duties may require working in a Controlled Environment Room (CER).


    Physical Demands:

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.


    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to walk and sit.


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