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Safety Writer

Freshers years
3 LPA to 5 LPA
50 May 28, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Communication Skills, CPC Certified, 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

Job Title: Safety Writer

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Location: Mumbai, India

Employment Type: Full Time

Date Posted: Today

Job Requisition ID: 2420412

Company Overview: Fortrea is a leading global Contract Research Organization (CRO) that provides a wide range of clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device industries. With over 19,000 staff in more than 90 countries, Fortrea is committed to transforming drug and device development worldwide.

Job Description:

  • Report Writing: Write various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Risk Management Plans. Author subject narratives for adverse drug reactions and serious adverse events.
  • Quality Control: Perform quality reviews of safety reports prepared by junior or associate medical writers.
  • Document Development: Develop strategies for report planning, lead kick-off meetings, and handle round table discussions for comment resolution.
  • Regulatory Compliance: Ensure operations comply with regulatory requirements and maintain high standards of documentation.
  • Literature Research: Conduct literature searches, review articles, and author literature abstracts/summaries.
  • Client Interaction: Coordinate with internal and external stakeholders to gather necessary inputs for documents.
  • Labeling: Participate in the creation and updating of labels such as Core Data Sheets and USPIs.
  • Process Improvement: Implement and promote efficient and quality processes to meet project timelines and deliverables.

Key Qualifications:

  • Experience in safety report writing and knowledge of regulatory submission formats.
  • Strong communication skills and ability to work collaboratively.
  • Proficient in conducting literature searches and document management.
  • Capable of managing multiple projects with stringent deadlines.

Equal Employment Opportunity: Fortrea is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, gender, national origin, age, disability, or any other legally protected characteristics.

Join Our Team: If you are a motivated problem-solver and creative thinker passionate about advancing clinical trials, join Fortrea. We offer a collaborative workspace that nurtures personal growth and allows you to make a global impact.

For more information about our company and to apply, visit www.fortrea.com.