Instagram
youtube
Facebook

Safety Science Analyst

2+ years
Not Disclosed
10 Sept. 27, 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 intended 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 in the processing of adverse events, including but not limited to:

    • 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).
    • Assisting in the listedness assessment against the appropriate label (for marketed products, if applicable).
    • Generating queries and collecting missing or discrepant 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.
  • Support the processing and submission of expedited and periodic reports to global regulatory agencies or other recipients (clients, regulatory authorities, ethics committees, investigators, and Fortrea project personnel), prioritizing these reports within regulatory and study-specific timelines.

  • Assist in database reconciliation as applicable.

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

  • Help maintain supporting documentation related to adverse event reporting requirements across all countries, if applicable.

  • Support the upload and archival of case, study, and project documentation as needed.

  • Build and maintain positive relationships with PSS across functional units.

  • Ensure compliance with regulatory requirements throughout operations.

  • Perform any other duties as assigned by management.

Equal Opportunity Employer Statement:

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