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Safety Writer

0-1 years
Not Disclosed
10 May 14, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview: Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and decades of clinical development expertise. Serving pharmaceutical, biotechnology, and medical device clients, Fortrea offers a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries and a team of over 19,000 professionals, Fortrea is revolutionizing drug and device development worldwide.

Position Title: Medical Writer

Job Description: Fortrea is actively seeking motivated individuals to join our team as Medical Writers. As a Medical Writer, you will play a crucial role in various aspects of clinical research and regulatory submissions, contributing to the development of safety reports, regulatory documents, and other essential materials. Key responsibilities include:

  • Perform data collection for report planning and strategy development.
  • Write safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and more.
  • Conduct quality review of safety reports prepared by junior or associate medical writers.
  • Author or contribute to ad hoc reports and benefit-risk evaluation reports.
  • Prepare medical information responses for healthcare professionals.
  • Contribute to signal reports and safety issue analysis reports.
  • Author subject narratives for adverse drug reactions and serious adverse events.
  • Participate in label creation and updates, including Core Data Sheets and Med Guides.
  • Conduct literature searches and review articles for various reports and surveillance activities.
  • Implement consistent and efficient processes to meet timelines and quality standards.
  • Ensure compliance with regulatory requirements and promote a culture of high customer service.
  • Perform additional activities as per project requirements and manager's discretion.

Qualifications:

  • Bachelor's and/or Master's degree in Healthcare or related field.
  • Strong communication and writing skills.
  • Familiarity with clinical research and regulatory requirements.
  • Ability to work collaboratively in a dynamic environment.
  • Detail-oriented with strong organizational skills.

Company Culture: Fortrea fosters a collaborative workspace where personal growth is encouraged, and innovation thrives. We are committed to revolutionizing the development process to deliver life-changing therapies to patients in need. Join our exceptional team and make a meaningful global impact.

Equal Opportunity Employer Statement: Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. We encourage all qualified individuals to apply.

Global Talent Network: Join Fortrea's Global Talent Network to stay connected, drive innovation, and contribute to our mission of advancing life-saving therapies for patients worldwide. As a member, you'll have access to exciting opportunities, industry trends, exclusive events, and company insights. Visit www.fortrea.com to learn more.