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    Medical Device Vigilance Associate (Hybrid)

    Baxter
    1-2 years
    $77,000 - $99,000 annually
    Deerfield
    10 May 17, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Medical Device Vigilance Associate (Hybrid)

    Req #: JR - 135826

    Location: Deerfield, Illinois, United States

    Job Category: GST Operations

    Date posted: 05/13/2024

    Apply Now

    Company Description: At Baxter, we are deeply connected by our mission to save and sustain lives. With a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, our products and therapies are vital in hospitals, clinics, and homes worldwide. We prioritize employee well-being and recognize the importance of a healthy work-life balance.

    Your Role at Baxter:

    As a Medical Device Vigilance Associate, your primary responsibility is to support the safety management of post-market products and global clinical trials, focusing on device and combination products. This involves adhering to applicable procedures, guidelines, and regulations.

    Responsibilities:

    • Review SAEs and product complaints/deficiencies data for completeness and clarity.
    • Initiate and manage SAE/device deficiency reports in the Baxter Device Clinical Trial Safety Database (DCTS).
    • Format documents for eTMF readiness and manage study document uploads in eTMF.
    • Maintain and manage the DCTS database alongside the IT team.
    • Support reconciliation of safety events with the Worldwide Medical Team.
    • Manage access control and content on the Medical Device Vigilance SharePoint site for clinical studies.
    • Generate case reports from DCTS and ensure timely submission to applicable functions.
    • Perform quality checks on all AEs and DDs entered into TW-DCTS.
    • Own standard operating procedures for DCTS and associated activities.
    • Support post-market complaint/adverse event case handling as needed.
    • Perform other duties to support device safety management.

    Qualifications:

    • Bachelor of Science (scientific field preferred).
    • 1-2 years of pharmaceutical and/or device clinical development experience preferred.
    • Working knowledge of FDA, ICH/GCP, and European Regulatory Authority requirements.
    • Excellent verbal and written communication skills.
    • Strong interpersonal and organizational skills.
    • Ability to multitask with attention to detail.
    • Proficiency in Microsoft Word, Excel, and Project.
    • Familiarity with Electronic Data Capture systems such as Medidata Rave preferred.
    • Working knowledge of safety reporting standards and coding systems preferred.

    Estimated Base Salary: $77,000 - $99,000 annually (subject to change based on market data and other factors)

    Equal Employment Opportunity: Baxter is an equal opportunity employer, evaluating qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, disability/handicap status, or any other legally protected characteristic.

    Reasonable Accommodations: Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require accommodation during the application or interview process, please inform us.

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