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    Safety Reporting Specialist - Remote

    Thermo Fisher Scientific
    2 years
    Not Disclosed
    15 May 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description:

    Role Overview:
    The Safety Reporting Specialist at Thermo Fisher Scientific is responsible for efficiently managing the receipt, submission, and tracking of expedited and periodic safety reports related to department projects. This role supports management in generating project metrics, contributes to project and program development in safety reporting, and may lead initiatives within this domain.

    Key Responsibilities:

    1. Safety Reporting Management:

      • Receive, prepare, and submit safety reports to relevant parties, escalating any encountered issues to lead or line managers.
      • Ensure timely submission of reports in compliance with regulatory timelines and country legislation.

    2. Metrics Production and Quality Assurance:

      • Assist in producing project metrics and promptly alert managers to any quality or timeline concerns.

    3. Project Involvement:

      • Participate in project teams and potentially lead small to moderate scope projects.
      • Provide training and support to team members as needed.

    4. Administrative Duties:

      • Perform administrative tasks such as filing and maintaining safety reporting systems and information.

    5. Cross-Departmental Liaison:

      • Collaborate with various departments on safety reporting tasks and client account setup.

    6. Audit Participation and Testing:

      • Participate in audits when required and perform testing activities as necessary.

    7. Continuous Improvement:

      • Share ideas and suggestions with team members, fostering effective communication.
      • Participate in process improvement initiatives to enhance operational efficiency.

    Education and Experience Requirements:

    • Bachelor's degree or equivalent with relevant formal academic/vocational qualification.
    • Minimum of 2 years of previous experience demonstrating the necessary knowledge, skills, and abilities.
    • Equivalency, comprising a combination of education, training, and/or directly related experience, may be considered in some cases.

    Knowledge, Skills, and Abilities:

    • Proficient in medical terminology.
    • Excellent written and verbal communication skills.
    • Strong proficiency in Microsoft Word and Excel, coupled with a solid understanding of safety database functionality.
    • Thorough knowledge of procedural documents and global safety reporting requirements, including FDA regulations and guidelines.
    • Ability to manage multiple tasks while ensuring high-quality results.
    • Meticulous attention to detail and accuracy.
    • Ability to handle sensitive information and data with maturity.
    • Effective interaction with all organizational levels.
    • Strong critical thinking and problem-solving skills.

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