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Medical Physician Specialist I

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: Medical Safety Expert (Post-Marketing)

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

Location: [Insert Location]


About Fortrea:

Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and clinical development excellence. With decades of experience, we provide comprehensive clinical development, patient access, and technology solutions across over 20 therapeutic areas. Operating in nearly 100 countries, Fortrea is transforming the development of drugs and devices for global partners and patients.


Position Overview:

We are seeking a Medical Safety Expert to provide post-marketing medical safety expertise directly and indirectly to Sponsors of drugs, devices, and combination products. This role focuses on medical review of cases, supporting regulatory compliance, and ensuring high-quality deliverables.


Key Responsibilities:

  • Conduct primary medical review of cases, including assessing seriousness, causality, listedness/labeling, adverse event coding, and narrative review.
  • Update and document daily case data and feedback in relevant tracking tools for efficient workflow management.
  • Ensure complete responsibility for assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.
  • Provide training and guidance on medical aspects of case processing to the team, after one year of tenure.
  • Participate in aggregate and signal analysis activities as required for single case processing.
  • Foster a culture of high customer service and accountability in all aspects of case processing.

Qualifications:

  • Education: Bachelor’s degree in medical science, MD, DO, or equivalent degree. Relevant experience may be considered in lieu of educational requirements.
  • Language Skills:
    • Speaking: English at ILR level 3+ or higher.
    • Writing/Reading: English at ILR level 4+ or higher.
  • Experience:
    • Working knowledge of medical sciences, diagnosis, therapeutics, and drug treatments.
    • Understanding of regulatory requirements for clinical research and ICH-GCP guidelines.
  • Preferred Qualifications:
    • 1-2 years of clinical practice experience.

Physical Demands/Work Environment:

  • Office or home-based environment, as directed by the line manager.

Why Join Fortrea?

At Fortrea, we are driven by a shared passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the clinical development process, enabling the swift delivery of life-changing therapies to patients. Join our team and make a meaningful global impact in a collaborative and growth-oriented workspace.


Fortrea is an Equal Opportunity Employer:

Fortrea values diversity and inclusion and does not tolerate discrimination or harassment of any kind. We make employment decisions based on business needs and individual qualifications. We encourage candidates from all backgrounds to apply.

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

If you require a reasonable accommodation due to a disability to complete your job application, pre-employment testing, job interview, or otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. This email address is for accommodation requests only and should not be used to check the status of your application.


Apply Now and Join Fortrea in Revolutionizing Drug and Device Development!