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    Senior Safety Writer

    Fortrea
    7-11 years
    Not Disclosed
    Mumbai
    10 May 15, 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

    Job Title: Safety Reports Writer and Regulatory Document Author

    Company Overview:
    Fortrea is a leading global contract research organization (CRO) dedicated to transforming drug and device development for partners and patients worldwide. With a focus on scientific rigor and decades of clinical development experience, Fortrea offers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries with a team of over 19,000 staff, Fortrea is committed to revolutionizing the clinical trial process to deliver life-changing therapies to patients in need.

    Job Description:

    Responsibilities:

    1. Write and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.
    2. Author and review Risk Management Plans (RMPs), adhoc reports, and medical device reports.
    3. Draft responses to health authority questions or feedback and collaborate with cross-functional stakeholders.
    4. Conduct trainings for peers and junior team members and provide shadowing opportunities.
    5. Author/review manuscripts, abstracts, and posters for conferences.
    6. Perform/review signal detection activities and author signal reports.
    7. Act as a writing coach, devise training programs, and author/review SOPs/WIs/process documents.
    8. Coordinate activities related to report writing across a team of writers, if applicable.
    9. Assist in estimation of resource requirements and responding to Requests for Proposals (RFPs).
    10. Internal and external communication and coordination to obtain required inputs.
    11. Create and update labels, review literature searches, and perform routine surveillance.
    12. Implement and promote consistent, efficient, and quality processes to meet timelines and deliverables.
    13. Ensure compliance with regulatory requirements and maintain a culture of high customer service.

    Qualifications:

    • Bachelor of Pharmacy degree
    • 7 to 11 years of experience in pharmaceutical regulatory writing
    • Expert proficiency in English language
    • Strong problem-solving skills and ability to think creatively
    • Commitment to diversity, inclusion, and equal opportunity employment

    Company Values: Fortrea is committed to fostering a diverse and inclusive workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, gender, national origin, age, disability, or any other legally protected characteristic. Fortrea encourages all qualified individuals to apply and join a collaborative workspace where personal growth is nurtured to make a meaningful global impact.

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

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