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Safety Physician

2+ years
Not Disclosed
10 Nov. 6, 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

Job Opportunity: Medical Reviewer at Fortrea

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are currently seeking a Medical Reviewer to join our dynamic team. In this role, you will be responsible for the primary medical review of cases, ensuring that all cases are assessed for seriousness, causality, adverse event coding, and narrative quality. The Medical Reviewer will work collaboratively with internal teams, contribute to process improvement initiatives, and support the training and development of the case processing team. The role is pivotal in ensuring the quality and integrity of medical case reviews.

Key Responsibilities:

  • Primary Medical Review: Perform medical assessments of adverse event cases, ensuring accurate coding, causality assessments, and narrative quality.
  • Case Management: Document daily case data and feedback into appropriate trackers/tools to maintain accurate workflow and case tracking.
  • Quality Assurance: Conduct secondary medical reviews (QC) and retrospective reviews of previously processed cases to identify error trends, areas of improvement, and training needs.
  • Signal Detection & Analysis: Participate in aggregate medical reviews and signal detection/analysis activities as required.
  • Training & Guidance: Provide training and guidance to the case processing team on medical aspects of case processing to ensure quality and compliance.
  • Client Relationship Management: Build and maintain strong client relationships, ensuring a high standard of customer service.
  • Process Improvement: Contribute to process improvement initiatives across the company, identifying opportunities to enhance case processing and review standards.

Required Qualifications:

  • Experience: Prior experience in medical review, pharmacovigilance, or related field.
  • Medical Knowledge: Strong understanding of medical terminology, adverse event coding, causality assessments, and regulatory guidelines.
  • Attention to Detail: Ability to review and assess medical cases with a focus on accuracy and completeness.
  • Communication Skills: Strong interpersonal and communication skills, with the ability to provide guidance and feedback to team members.
  • Compliance: Familiarity with pharmacovigilance regulations, including ICH-GCP and regional regulatory requirements.
  • Problem-Solving: Ability to identify trends and areas for improvement in case processing and review activities.

Education:

  • Medical Degree or relevant qualification in Life Sciences or related field.

Location: [Insert Location]

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual, without discrimination on the basis of race, religion, gender, disability, veteran status, sexual orientation, gender identity, or any other legally protected characteristic.