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    Safety Writer

    Fortrea
    2+ years
    Not Disclosed
    Mumbai
    10 Oct. 15, 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

    About Fortrea

    As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and boasts decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device clients with a comprehensive 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 worldwide.

    Key Responsibilities:

    • Conduct data collection for report planning, develop strategies, and lead kick-off meetings and roundtable discussions to resolve comments.
    • Write various safety reports for global regulatory submissions, including Annual Reports (IND and others), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Reports, Risk Management Plans, and other related documents. Collaborate with internal and client stakeholders to gather necessary inputs.
    • Perform quality reviews of safety reports prepared by junior or associate medical writers.
    • Author or contribute to ad hoc reports, benefit-risk evaluation reports, and supporting documents for label updates.
    • Write Common Technical Document summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned.
    • Prepare medical information responses for healthcare professionals (HCPs).
    • Author and contribute to signal reports (both ad hoc and periodic) and safety issue analysis reports.
    • Write subject narratives for adverse drug reactions and serious adverse events.
    • Coordinate internal and external communications to obtain necessary inputs.
    • Participate in creating and updating labels, such as Core Data Sheets, USPI, centralized SPCs, and Med Guides.
    • Conduct literature searches to support various report types or routine surveillance activities. Review and propose updates to search strategies, and evaluate articles selected by junior writers. Author literature abstracts/summaries and propose company comments.
    • Implement and promote consistent, efficient, and quality processes to meet timelines and deliverables as per standard operating procedures, while taking accountability for outcomes.
    • Ensure operational compliance with regulatory requirements.
    • Foster a culture of high customer service and accountability.
    • Perform additional activities as required by project needs or managerial discretion after completing relevant training.

    Join Our Team

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our commitment to overcoming challenges in clinical trials. We aim to revolutionize the development process, ensuring the rapid delivery of life-changing therapies to patients in need. Join our exceptional team and enjoy a collaborative work environment that nurtures personal growth, enabling you to make a meaningful global impact.

    For more information about Fortrea, visit www.fortrea.com.

    Equal Opportunity Employer

    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. Employment decisions are made based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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

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