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    Serialization Analyst

    Eversana
    2+ years
    Not Disclosed
    Pune
    10 Nov. 7, 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

    DSCSA Serialization Analyst

    Location: Remote (U.S. Based)
    Company: EVERSANA

    About EVERSANA

    At EVERSANA, we are proud to be recognized as a Great Place to Work globally. With over 7,000 employees, we are united by a shared vision to create a healthier world. We provide innovative commercialization services to the life sciences industry and serve over 650 clients, ranging from emerging biotech startups to established pharmaceutical leaders. Our mission is to bring groundbreaking therapies to market and support the patients who depend on them. Join us, and together we’ll make an impact.

    Position Overview

    The DSCSA Serialization Analyst is responsible for supporting the serialization process within the pharmaceutical supply chain. This role works closely with clients, customers, and internal teams to ensure successful DSCSA regulatory compliance, EPCIS file integration, and issue resolution. The analyst will manage day-to-day serialization activities, coordinate vendor interactions, and help ensure smooth integration into production environments.

    Key Responsibilities

    • Client and Customer Interface: Directly support clients and their customers in the serialization integration process, ensuring compliance with DSCSA regulations.
    • Implementation and Testing: Assist with DSCSA implementation, including EPCIS file generation, testing, and transition to production.
    • File Management: Manage and resolve EPCIS file variances and support shipment discrepancies.
    • EDI Support: Collaborate with the EDI team for DSCSA electronic document processing.
    • Vendor Coordination: Work with vendors and technology teams to implement serialization projects and troubleshoot open issues.
    • Documentation: Maintain project documentation, track progress, and manage current serialization activities.
    • Compliance Focus: Ensure adherence to Drug Supply Chain Security Act (DSCSA) and Electronic Product Code Information Services (EPCIS) standards.
    • Diversity, Equity, and Inclusion: Demonstrate a commitment to DEI through continuous personal development and the modeling of inclusive behaviors.

    Qualifications

    • Education: Bachelor's degree or equivalent experience.
    • Experience:
      • Minimum of EDI experience is required.
      • Preference for experience with EPCIS / XML and understanding of serialization solutions.
      • Familiarity with Tracelink, Rfxcel, or other serialization providers is a plus.
    • Skills:
      • Knowledge of AS2, sFTP, and other communication protocols.
      • Strong understanding of serialization processes and DSCSA compliance.
      • Proficient in analyzing XML file-based data exchanges.
    • Technology:
      • Experience with Sterling Integrator is a plus.

    Additional Information

    EVERSANA is an Equal Opportunity Employer. We believe in creating a diverse, inclusive environment that encourages collaboration and innovation. Our team is committed to fostering diversity in all its forms, including race, gender, age, disability, veteran status, sexual orientation, religion, and beyond. Every employee’s unique perspective contributes to our success, and inclusion is everyone’s responsibility.

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