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    Safety Science Coordinator I

    Fortrea
    1-2 years
    Not Disclosed
    Bangalore
    10 July 1, 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, 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

    Company Overview

    Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

    Summary of Responsibilities

    Safety Report Processing

    • Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs):
      • Maintain adverse event tracking systems.
      • Set up and maintain project files and central documentation files.
      • Report ESRs & PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel within study-specified timelines.
      • Log all incoming Adverse Event (AE)/Serious Adverse Event (SAE) reports into the departmental tracking application and forward to the centralized mailbox.

    Adverse Event Processing

    • Data Entry and Narratives:
      • Enter safety data into adverse event tracking systems.
      • Write patient narratives and accurately code adverse events using MedDRA (for Marketed products, if applicable).
    • Listedness Assessment:
      • Assist in the listedness assessment against the appropriate label (for Marketed products, if applicable).
    • Queries and Reporting:
      • Generate queries for missing or discrepant information in consultation with medical staff, if needed.
      • Submit expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, partners, and Fortrea project personnel within agreed timelines.

    Quality and Compliance

    • Peer/Quality Review:
      • Assist with peer/quality review of processed reports and support with trends and actions as needed.
    • Database Reconciliation:
      • Assist in the reconciliation of databases, as applicable.
    • Regulatory Requirements:
      • Maintain files regarding adverse event reporting requirements in all countries.
      • Ensure compliance with governing regulatory requirements and applicable study/project specific plans.
      • Work within the Quality Management System framework, including Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).

    Administrative and Support Tasks

    • Safety Study Files:
      • Prepare and support coordination of safety study files for archiving at project completion.
    • Meetings/Teleconferences:
      • Arrange and schedule internal and/or external meetings/teleconferences.
    • Training and Mentorship:
      • Train and mentor PSS Assistants or peers in their day-to-day activities.
    • PSS Relationships:
      • Build and maintain good relationships across functional units.
    • Administrative Support:
      • Provide administrative support to PSS personnel.

    Additional Duties

    • Perform any additional activities per project requirement or at the manager’s discretion upon completion of relevant training.
    • Assume responsibility for the quality of data processed.

    Qualifications/Experience

    Minimum Requirements

    • Non-Degree: 1-2 years of safety experience or relevant experience.
    • Associate Degree: 6 months to 1 year of safety experience or relevant experience.
    • PharmD: 0-6 months of safety experience or relevant experience.

    Preferred Degree Disciplines

    • Biological Sciences
    • Pharmacy
    • Nursing
    • Medical Sciences
    • Life Sciences
    • Related area

    Safety Experience

    • Experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.

    Relevant Experience

    • Experience in the pharmaceutical, biotechnology, or CRO industry in areas such as:
      • Medical Affairs
      • Clinical Data Entry and Clinical Data Management
      • Clinical Data Monitoring
      • Regulatory Affairs
      • Quality Assurance

    Company Values

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering 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 embrace a collaborative workspace where personal growth is nurtured, 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 the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and qualifications, without regard to race, religion, color, national origin, gender, family status, sexual orientation, age, veteran status, disability, or any other legally protected characteristic. We encourage all to apply.

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

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