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Safety Science Analyst

2+ years
Not Disclosed
12 Sept. 26, 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

These statements outline the general nature of the job and are not meant to be an exhaustive list of all responsibilities, skills, and duties.

Key Responsibilities:

  • Perform case intake and triage of incoming safety information or reports from various sources, including spontaneous reports and clinical trials.

  • Assist with processing adverse events, which includes:

    • Data entry of safety information into adverse event tracking systems.
    • Writing patient narratives and accurately coding adverse events using MedDRA (for marketed products, if applicable).
    • Supporting the assessment of listedness against the appropriate label (for marketed products, if applicable).
    • Generating queries and collecting missing or inconsistent information in consultation with medical staff as needed.
    • Submitting expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, and Fortrea project personnel within agreed timelines.
  • Assist with the processing and submission of expedited and periodic reports to global regulatory agencies and other stakeholders (Clients, Regulatory Authorities, Ethics Committees, etc.), ensuring timely processing within applicable regulatory or study-specific timelines.

  • Support the reconciliation of databases as needed.

  • Work within the Quality Management System framework, adhering to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs) as appropriate.

  • Maintain supporting files and documentation regarding adverse event reporting requirements in all applicable countries.

  • Support the upload and archival of case/study/project documentation as necessary.

  • Foster and maintain strong relationships across functional units.

  • Ensure compliance with regulatory requirements in operational processes.

  • Undertake any other duties as assigned by management.

Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea is committed to diversity and inclusion in the workplace. We do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions), family or parental status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.