• Product Safety Coordinator

    Category Clinical Development
    ID
    2018-1229
    Job Location
    US-MD-Rockville
    Type
    Regular Full-Time
  • Overview

    MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

     

    The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

    Summary of Position

    This is an individual contributor position responsible for assisting in the management of adverse event reports. The incumbent in this role will support pharmacovigilance activities including but not limited to: adverse event data entry into the safety database; reconciliation of the safety database with clinical databases, exchanging safety information with business partners and other vendors; and providing general administrative support.

    Responsibilities and Job Duties

    • Receive and enter adverse event report information into the safety database 
    • Assist in the maintenance of safety files and documentation that is compatible with the department and corporate document management system and ensure regulatory compliance
    • Reconcile serious adverse events between the safety and clinical study databases by comparing listings from the clinical study database and the safety database, identifying and documenting the discrepancies, drafting queries to resolve the discrepancies, providing the queries to the clinical data manager and product safety specialist as appropriate, monitoring resolution of the discrepancies, and escalating discrepancies that are not resolved in a timely manner to the study project manager.
    • Generate and send regulatory forms and/or XML files to Business Partners and perform a periodic reconciliation of the exchange by reviewing listings and confirming that all reports included in the listing were sent to the Business Partner.
    • Assist in the creation and formatting of safety data collection forms, tracking reports, flowcharts, templates, job aids, and training materials.
    • Other related administrative responsibilities and duties, as required by business need and/or assigned by manager

     

    Qualifications

    Education & Other Credentials

     

    Bachelor of Science degree in Life Sciences, Nursing, Pharmacy, or related field

    Experience

    No previous pharmacovigilance/drug safety experience required

    Knowledge, Skills and Abilities

    • Strong organizational skills, including the ability to prioritize independently with minimal supervision
    • Ability to manage several high-priority, fast-paced activities within required timelines
    • Strong attention to detail and ability to create quality work in a timely fashion
    • Ability to work independently as well as in a team environment
    • Strong interpersonal, collaborative, and communication skills
    • Proficiency in MS Office suite
    • Demonstrate an aptitude for learning and adhering to standard operating procedure

    Supervisory Responsibilities

    No

    Preferred Qualifications

    • Experience with Argus Safety Database
    • Familiarity with SharePoint

     

     

    Statement

    MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

    Equal Opportunity Employer/Veterans/Disabled

     

    For more information about our commitment to equal employment opportunity, please click here.

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