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    Operation Specialist1

    Iqvia
    3+ years
    Not Disclosed
    Dalian
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

     

    Job Description

    Position Title: Safety Data Processor

    Company: IQVIA

    Position Overview

    As a Safety Data Processor, you will be responsible for reviewing, assessing, and processing safety data and information across various service lines. This includes distributing reports and data to internal and external parties in compliance with applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines. This role requires you to work under the guidance of senior operation team members.

    Key Responsibilities

    • Training and Compliance:

      • Prioritize and complete required training on time.
      • Ensure compliance with all project-related processes and activities.
      • Read and acknowledge all necessary IQVIA and customer SOPs.

    • Safety Data Processing:

      • Process safety data according to regulations, guidelines, SOPs, and project requirements.
      • Perform Pharmacovigilance activities, including tracking adverse events (AEs) and endpoint information.
      • Perform initial and update status determinations for incoming events.
      • Enter data into safety databases, code AEs and products, and write narratives.
      • Ensure quality and productivity standards are met according to project requirements.

    • Case Management:

      • Create, maintain, and track cases as per the project plan.
      • Identify quality problems and communicate them to senior team members.
      • Provide problem-solving support when necessary.

    • Collaboration and Communication:

      • Liaise with various functional teams (e.g., project management, clinical, data management) and healthcare professionals to address project-related issues.
      • Liaise with clients regarding case processing activities.

    • Mentorship and Support:

      • Mentor new team members, as assigned by the Manager.
      • Attend project team meetings and provide feedback to the operations manager.

    • Medical Review (if applicable):

      • Perform medical review of non-serious AEs and ADRs, including coding, assessing causality, and reviewing medical history and concomitant medications.
      • Ensure the completeness and accuracy of data according to guidelines and regulations.

    • General Responsibilities:

      • Lead or support department initiatives.
      • Maintain 100% compliance with people practices and processes.

    Qualifications

    • Education:

      • High School Diploma or equivalent in a scientific or healthcare discipline.
      • Bachelor's degree in life sciences or related field (preferred).
      • Up to 3 years of relevant experience, including up to 1 year in Pharmacovigilance.

    • Skills and Experience:

      • Good knowledge of medical terminology.
      • Working knowledge of safety databases and related applications.
      • Familiarity with global, regional, and local clinical research regulatory requirements.
      • Strong attention to detail and accuracy.
      • Good working knowledge of Microsoft Office and web-based applications.
      • Strong organizational, time management, and multitasking skills.
      • Strong verbal and written communication skills.
      • Self-motivated with the ability to work independently and as a team player.
      • Ability to handle competing priorities and changing demands.
      • Flexibility to work shifts and occasional travel.

    About IQVIA

    IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We push the boundaries of human science and data science to make the greatest impact in improving global health.

    Learn more at IQVIA Careers.

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