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    Assoc Mdr/Vigilance Spec - Exempt

    Hire Talent
    0-2 years
    Not Disclosed
    Mountain View
    10 Aug. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Associate MDR/Vigilance Specialist
    Location: Mounds View Campus (On-site Mon/Tues, Remote Wed-Fri)
    Hours: 40 hours/week
    Education Required: Bachelor's Degree
    Experience Required: 0-2 years
    Posted On: 8/6

    Job Description

    Role Overview:
    As an Associate MDR/Vigilance Specialist, you will be responsible for documenting and evaluating product feedback and analysis results to determine complaint and regulatory reporting status according to US and OUS (Outside the United States) regulatory guidelines. You will compile regulatory agency reports, monitor complaint activity, and ensure timely review and closure of product complaints.

    Key Responsibilities:

    • Apply policies and procedures to comply with FDA and OUS regulations.
    • Monitor the company’s drug or medical device surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse event reports.
    • Evaluate incoming information to determine eligibility for Medical Device Reporting (MDR) and Vigilance reporting.
    • Ensure complete, accurate, and timely submission of MDRs, Vigilance Reports (VR), and Adverse Drug Experience (ADE) data as required by regulatory agencies.
    • Interface and collaborate with internal and external contacts to ensure efficient and customer-focused collection of complaint information.
    • Maintain awareness of new products, government regulations, and reporting requirements.
    • Act as a liaison with internal teams and external collaborators to develop programs and processes that meet regulatory reporting requirements.
    • Perform additional duties as assigned.

    Must-Have Qualifications:

    • Bachelor’s degree.
    • High level of computer proficiency (e.g., Microsoft Office, SAP, Siebel, Oracle Clinical).
    • 0-2 years of experience in healthcare, medical device, or pharmaceutical industries with a focus on safety or clinical data evaluation.

    Preferred Qualifications:

    • Degree in Health Care, Sciences, or Bio-Medical Engineering.
    • Experience in the medical device industry.
    • Strong verbal and written communication skills.
    • Knowledge of basic anatomy and physiology.
    • Strong attention to detail.
    • High level of computer proficiency.

    Additional Information:

    • Autonomy: Entry-level individual contributor with close supervision.
    • Organizational Impact: Works on smaller, less complex projects with limited scope.
    • Innovation and Complexity: Identifies and addresses minor problems, making minor system and process changes.
    • Communication and Influence: Primarily communicates with internal contacts to gather, confirm, and convey information.
    • Leadership and Talent Management: Focused on self-development, with no direct leadership responsibilities.

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    Equal Opportunity Employment:
    We are a Consciously Unbiased™ organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Best regards,
    HireTalent Recruiting Team
    www.consciouslyunbiased.com

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