Safety Writer

2+ years

Not Disclosed

Mumbai

10 Oct. 22, 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

Job Title: Medical Writer
Location: [Location TBD]

Join Fortrea: Transforming Clinical Development

As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and has decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device clients with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is at the forefront of transforming drug and device development for partners and patients worldwide.

Key Responsibilities

Data Collection & Strategy: Perform activities related to data collection for report planning. Develop strategies and lead kick-off meetings and round table discussions for comment resolution.
Safety Reports: Write various safety reports for global regulatory submissions, including Annual Reports (IND and others), Periodic Safety Update Reports, Development Safety Update Reports, and Risk Management Plans. Take ownership of assigned deliverables, collaborating with internal and client stakeholders to gather necessary inputs.
Quality Review: Conduct quality reviews of safety reports prepared by junior or associate medical writers.
Regulatory Documents: Author or contribute to Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other assigned regulatory documents.
Medical Information Responses: Prepare responses for healthcare professionals (HCPs).
Signal Reports & Narratives: Author/contribute to signal reports, safety issue analysis reports, and subject narratives for adverse drug reactions and serious adverse events.
Communication & Coordination: Manage internal and external communication to gather required inputs.
Label Updates: Participate in creating and updating labels, such as Core Data Sheets, USPI, and Med Guides.
Literature Searches: Conduct literature searches for report authoring and routine surveillance activities. Review selected articles and propose updates to search strategies.
Process Improvement: Implement and promote consistent, efficient, and quality processes to meet timelines and deliverables, ensuring compliance with regulatory requirements.
Customer Service: Create and maintain a culture of high customer service.
Additional Duties: Perform any other activities as required by the project or manager’s discretion, following relevant training.

Join Our Team

Fortrea is actively seeking motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and thrive in a collaborative workspace that nurtures personal growth and enables you to make a meaningful global impact.

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 discrimination based on any legally protected characteristics. We encourage all qualified candidates to apply.

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

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Safety Writer

Job Description

Join Fortrea: Transforming Clinical Development

Key Responsibilities

Join Our Team

Equal Opportunity Employer

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