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    Case Management Specialist (Remote)

    Jazz Pharmaceuticals
    3+ years
    $80,000.00 - $120,000.00
    Remote, USA
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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: Case Management Specialist (CMS)

    Company Overview:

    Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company dedicated to transforming the lives of patients and their families through innovative medicines. We focus on developing life-changing treatments for serious diseases with limited or no existing therapeutic options. Our diverse portfolio includes marketed medicines and novel candidates in neuroscience and oncology, ranging from early to late-stage development. Headquartered in Dublin, Ireland, Jazz Pharmaceuticals serves patients in nearly 75 countries. For more information, visit Jazz Pharmaceuticals and follow us on Twitter @JazzPharma.

    Job Description:

    The Case Management Specialist (CMS) plays a crucial role in the accurate and timely collection, safety review, processing, and reporting of adverse event data, ensuring compliance with global regulations and Jazz Pharmaceuticals' standard operating procedures. The CMS will support clinical safety management activities, act as the point of contact for clinical studies, and oversee adverse event workflow configuration and maintenance.

    Key Responsibilities:

    • Develop and maintain governance procedures for ICSR processing, data entry guidelines, coding conventions, and quality review in the Global Safety Database.
    • Ensure adherence to global regulatory requirements and Jazz Pharmaceuticals' standards for case processing.
    • Respond to regulatory and pharmacovigilance-related queries in a timely manner.
    • Manage adverse event inquiries from clinical trials and other sources, ensuring quality control and accuracy.
    • Collaborate with cross-functional teams for compliance, deviation investigations, root cause analysis, and corrective actions.
    • Lead safety vendor training and manage pharmacovigilance sections in clinical trial master files.
    • Oversee clinical study-related safety management activities, including study startup, reconciliation, and closure.
    • Participate in the development and maintenance of PV operations guidance documents and departmental policies.
    • Assist in special projects and may serve as a project manager or business process owner.
    • Mentor other team members and support audits and inspections to maintain inspection readiness.
    • Stay updated with pharmacovigilance practices and regulatory guidelines.

    Required Knowledge, Skills, and Abilities:

    • Minimum of 3 years of experience in pharmaceutical drug safety or pharmacovigilance operations (clinical safety experience preferred).
    • Proficiency in Argus safety database and case processing workflow.
    • Strong understanding of global safety reporting requirements and quality management systems.
    • Experience with MedDRA coding and medical terminology.
    • Excellent analytical, problem-solving, and communication skills.
    • Ability to work independently and as part of a multidisciplinary team in a fast-paced environment.
    • Flexibility to work outside of normal hours if required.

    Education and Licenses:

    • Required: BS/BA degree in a health-related or biological science field.
    • Preferred: Nursing or PharmD degree.

    Compensation and Benefits:

    For U.S.-based candidates, the base salary range for this role is $80,000 - $120,000, with compensation depending on qualifications, skills, experience, and other factors. In addition to base pay, the successful candidate may be eligible for a discretionary annual cash bonus, equity grants, and a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) retirement plan, and flexible paid vacation. For more details on our benefits offerings, visit Jazz Benefits.

    Equal Opportunity Employer:

    Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

    Application Information:

    Current Jazz employees should apply via the Internal Career site. For any accommodations needed during the application process, please contact us at QuestionForHR@jazzpharma.com.

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