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    Principal Safety Writer

    Fortrea
    5-7 years
    Not Disclosed
    Mumbai
    10 Feb. 13, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./PhD/M.Sc./B.Pharm/M.Pharm/Life science 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

    Principal Safety Writer

    Location: Mumbai
    Category: Clinical
    Job ID: 2447515

    Description:
    Fortrea, a leading global contract research organization (CRO), is dedicated to scientific rigor and clinical development excellence. We provide pharmaceutical, biotechnology, and medical device customers with comprehensive clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in nearly 100 countries, we are transforming drug and device development worldwide.

    Job Overview:

    • Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports.
    • Independently manage the production of safety deliverables, including complex data analyses and important safety issues.
    • Act as a technical lead within medical writing teams, providing guidance and expertise to ensure high-quality scientific content.
    • Establish effective communication and coordination within writing teams and with clients.
    • Contribute to scientific publications and represent the company at scientific meetings and conferences.
    • Support quality and process improvement initiatives.

    Summary of Responsibilities:

    • Author and review safety reports for global regulatory submissions, including but not limited to:
      • Annual Reports (IND and others)
      • Periodic Safety Update Reports
      • Periodic Adverse Drug Experience Reports
      • Development Safety Update Reports
      • Clinical Overviews
      • Medical Device Reports
    • Lead the report production process, ensuring quality standards and key deadlines are met.
    • Act as the primary point of contact for clients regarding report management activities.
    • Author/review RMPs, ad hoc reports, benefit-risk evaluation reports, and other safety deliverables.
    • Participate in the signal management process, providing input on data retrieval, safety databases, and scientific literature.
    • Engage in safety/benefit-risk review meetings, proposing label updates and risk mitigation measures in collaboration with safety physicians.
    • Draft responses to health authority questions and collaborate with cross-functional teams.
    • Develop abstracts, posters, manuscripts, and other scientific publications.
    • Act as a writing coach, providing quality feedback, training, and best practice sharing.
    • Support project management activities, tracking compliance and project schedules.
    • Contribute to business development efforts, including responding to RFPs and estimating resource requirements.
    • Create and update regulatory labels, including Core Data Sheets, USPI, and SPCs.
    • Conduct literature reviews and formulate search strategies for complex topics.
    • Implement consistent, efficient, and quality processes to meet regulatory requirements.
    • Ensure compliance with regulatory guidelines and pharmacovigilance standards.
    • Perform other duties as assigned.

    Qualifications (Minimum Required):

    • Bachelor’s degree in life sciences or equivalent.
    • Relevant and equivalent experience may be considered in lieu of educational requirements.

    Experience (Minimum Required):

    • 5-7 years of experience in the pharmaceutical industry, with at least 4 years in medical writing.
    • Strong command of written and spoken English.
    • Excellent written and verbal communication skills.
    • Proficiency in MS Office.
    • Strong organizational and time management skills.
    • Excellent interpersonal and leadership abilities.
    • Good understanding of regulatory requirements, pharmacovigilance practices, and ICH GCP guidelines.
    • Extensive knowledge of US, EU, and emerging market regulatory submission guidelines.
    • Ability to work independently and mentor junior team members.
    • Strong knowledge of regulatory documentation requirements.
    • Experience in project management and operations performance management.

    Preferred Qualifications:

    • Advanced degree (PhD or Master’s) preferred.
    • Experience in drug discovery and pharmacovigilance is desirable.

    Physical Demands/Work Environment:

    • Office environment or remote work setup.
    • Availability for up to 15% travel, including overnight stays as required.

    Fortrea is actively seeking motivated problem-solvers and creative thinkers committed to transforming clinical trials. Join our team to drive impactful change in drug and device development. Visit www.fortrea.com for more information.

    Equal Opportunity Employer:
    Fortrea is an Equal Opportunity Employer, ensuring a diverse and inclusive workforce. Employment decisions are based on business needs and individual qualifications. We encourage all qualified individuals to apply.

    For details on how we collect and store personal data, please review our Privacy Statement.

    For accommodation requests during the hiring process, contact: taaccommodationsrequest@fortrea.com.

     

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