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Safety Science Analyst

0-2 years
Not Disclosed
10 March 19, 2025
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

Job Title: Clinical Safety Associate

Company: Fortrea, a Global Contract Research Organization (CRO)

Location: [Insert Location]


Job Overview:

Fortrea is looking for a Clinical Safety Associate to assist with Clinical Safety and/or Post-Marketing Surveillance (PSS) operations associated with products. The role will involve managing and processing adverse events, including safety data collected from clinical trials and post-marketing settings. This includes submitting reports to clients and regulatory agencies within required timelines. The Clinical Safety Associate will be responsible for ensuring a high level of service to both internal and external clients, while complying with relevant legal requirements related to health and safety.


Summary of Responsibilities:

  • Perform case intake and triage of incoming safety information or reports from various sources, including clinical trials.
  • Assist with processing adverse events, including:
    • Data entry of safety data into adverse event tracking systems.
    • Writing patient narratives and coding adverse events accurately using MedDRA (for marketed products, if applicable).
    • Assisting with listedness assessment against appropriate labels (for marketed products, if applicable).
    • Generating queries and collecting missing or discrepant information in consultation with medical staff.
  • Submit expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, and Fortrea project personnel within the agreed timelines.
  • Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (clients, regulatory authorities, ethics committees, investigators, and Fortrea project personnel).
  • Reconcile databases and prioritize reports within regulatory timelines.
  • Work within the Quality Management System framework, including SOPs and departmental Work Instructions.
  • Assist in maintaining supporting files and documentation regarding adverse event reporting requirements in all countries.
  • Support the upload and archival of case/study/project documentation as needed.
  • Build and maintain good PSS relationships across functional units.
  • Ensure compliance with governing regulatory requirements.
  • Perform all other duties as assigned.

Qualifications (Minimum Required):

  • Non-Degree or 6 months - 1 year of safety experience* or relevant experience**.
  • Associate Degree with 0-6 months of safety experience* or relevant experience**.
  • BS/BA with 0-6 months of safety experience* or relevant experience**.
  • MS/MA with 0 years of safety experience* or relevant experience**.
  • PharmD with 0 years of safety experience* or relevant experience**.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Relevant experience includes working in the pharmaceutical, biotechnology, or CRO industry, particularly in areas such as Medical Affairs, Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.


Experience (Minimum Required):

  • Attention to detail.
  • Team player with solid written and verbal communication skills.
  • Accuracy in handling numerical data and proofreading.
  • Knowledge of MS Office applications.
  • Ability to operate standard office equipment.

Physical Demands/Work Environment:

  • Office environment or remote, as applicable.

Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea promotes diversity and inclusion in the workplace and does not tolerate harassment or discrimination. We make employment decisions based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, sexual orientation, age, veteran status, disability, or any other legally protected characteristic.

For more information about how we collect and store your personal data, please see our Privacy Statement.

If you require a reasonable accommodation for the application process or interviews due to a disability, please contact: taaccommodationsrequest@fortrea.com.