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    Safety Writer

    Fortrea
    0-2 years
    Not Disclosed
    Mumbai
    10 Sept. 10, 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:

    Fortrea is a globally recognized contract research organization (CRO) with a dedication to scientific precision and decades of expertise in clinical development. We provide a wide range of clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device clients across more than 20 therapeutic areas. With a workforce of over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of transforming drug and device development for patients and partners worldwide.

    Job Summary:

    The successful candidate will be responsible for key tasks related to the planning, preparation, and quality review of safety reports and regulatory submissions. This includes gathering data, developing strategies, leading kick-off meetings, and conducting discussions for comment resolution. The role involves writing and reviewing a variety of safety reports for global regulatory submissions, such as Annual Reports, Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and other key documents. The candidate will also collaborate closely with internal teams and external stakeholders to ensure compliance and quality.

    Key Responsibilities:

    • Lead allied activities like data collection for report planning, strategy development, and roundtable discussions for comment resolution.
    • Write safety reports for global regulatory submissions, including but not limited to Annual Reports, PSURs, PADERs, DSURs, and RMPs.
    • Take ownership of assigned deliverables and work with internal teams and clients to gather necessary inputs.
    • Conduct quality reviews of safety reports prepared by junior or associate medical writers.
    • Author or contribute to ad hoc reports, benefit-risk evaluations, and justification documents for label updates.
    • Write Common Technical Document (CTD) summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents.
    • Prepare responses to medical information requests from healthcare professionals.
    • Author or contribute to signal detection reports (both ad hoc and periodic) and safety analysis reports.
    • Write subject narratives for adverse drug reactions and serious adverse events.
    • Coordinate internal and external communications to gather required information for reports.
    • Participate in creating and updating labels, including Core Data Sheets, US Package Inserts (USPI), centralized Summary of Product Characteristics (SPCs), and Medication Guides.
    • Conduct literature searches for authoring reports or routine surveillance activities, proposing updates to search strategies when necessary.
    • Review articles selected by other writers and author literature abstracts or summaries, providing company comments where appropriate.
    • Implement efficient and high-quality processes to meet project timelines and ensure compliance with standard operating procedures (SOPs).
    • Ensure compliance with all regulatory requirements and maintain high standards of customer service and accountability.
    • Perform any additional duties as assigned upon completion of relevant training.

    Qualifications:

    • Proven experience in medical writing, regulatory submissions, or pharmacovigilance.
    • Strong knowledge of global regulatory requirements for safety reporting and documentation.
    • Experience authoring a variety of regulatory documents such as PSURs, DSURs, and RMPs.
    • Excellent writing skills with strong attention to detail and the ability to manage multiple projects.
    • Effective communication skills and the ability to work collaboratively with internal teams and external clients.

    Why Fortrea?

    At Fortrea, we seek motivated problem-solvers and creative thinkers who are passionate about overcoming challenges in clinical trials. We foster a collaborative environment that supports personal growth while making a meaningful global impact. Join us in revolutionizing drug development and delivering life-changing therapies to patients in need.

    Equal Opportunity Employer:

    Fortrea is an Equal Opportunity Employer committed to promoting diversity and inclusion in the workplace. We make employment decisions based on business needs and the qualifications of individuals. We do not tolerate discrimination or harassment based on race, religion, color, national origin, gender, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified applicants to apply.

    For more information on how we manage personal data, please review our Privacy Statement.

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