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    Lead Safety Science Specialist

    Fortrea
    5+ years
    Preffered by Company
    Bangalore
    10 Aug. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Overview

    Fortrea, a leading global Contract Research Organization (CRO), is at the forefront of transforming drug and device development. With a team of over 19,000 professionals operating in more than 90 countries, we offer innovative solutions across clinical development, patient access, and technology in over 20 therapeutic areas. Our commitment to scientific rigor and extensive clinical experience drives us to deliver exceptional value to our pharmaceutical, biotechnology, and medical device partners.

    Role Responsibilities

    As a key member of our team, you will:

    • Adverse Event Management: Oversee the receipt and processing of adverse event reports from various sources, including clinical trials. Responsibilities include safety database entry, AE review, patient narrative writing with coding, follow-up for missing information, and listed-ness assessment for marketed products.
    • Expedited Reporting: Submit Serious Adverse Event (SAE) reports promptly to clients, regulatory authorities, ethics committees, investigators, and other relevant parties within specified timelines.
    • Regulatory Compliance: Prioritize cases for expedited reporting to regulatory agencies, ensuring compliance with regulatory and study-specific timelines.
    • Pharmacovigilance Reporting: Prepare timely pharmacovigilance reports, including Individual Case Summary Reports (ICSRs), Annual IND Reports, European Annual Safety Reports (ASRs), Development Safety Update Reports (DSURs), Periodic Reports (PRs), and aggregate reports.
    • Quality Control: Perform peer and independent quality checks of safety reports as needed.
    • Data Reconciliation: Collaborate with Data Management or clients to reconcile safety databases.
    • SOP Adherence: Maintain a thorough understanding of Fortrea’s safety database conventions, Standard Operating Procedures (SOPs), Work Instructions (WIs), and related safety management guidelines.
    • Signal Detection: Assist in identifying safety signals, trends, and patterns.
    • Workflow Monitoring: Monitor workflow to ensure that all timelines are adhered to.
    • Procedure Development: Contribute to the development of departmental WIs and SOPs.
    • Reporting: Generate and review monthly status and project-specific reports, ensuring accuracy and quality of data.
    • Training and Support: Support and train less experienced safety staff in case-handling and adverse event reporting.
    • Safety Plans: Begin preparing Safety Management Plans (SMPs) and other safety-specific plans under supervision.
    • Decision Making: Make informed decisions regarding adverse event reporting based on project guidelines.
    • Client Liaison: Actively participate in project team and client meetings, providing updates and liaising as needed.
    • Quality Resolution: Proactively address quality issues and support audit and inspection preparations.
    • Data Review: Assist in reviewing cumulative safety data for Drug Safety Monitoring Boards (DSMBs), regulatory authorities, or clients.
    • Committee Coordination: Help set up and provide data to Safety Committees/DSMBs and coordinate endpoint committees as required.
    • Relationship Building: Foster strong relationships across functional units and demonstrate role-specific competencies and company values.

    Qualifications

    • Experience: Minimum of 5 years in a relevant field.
    • Education: Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related discipline preferred.

    About Fortrea

    At Fortrea, we are driven by a passion for overcoming clinical trial barriers and revolutionizing the development process to deliver life-changing therapies to patients. We are committed to creating a collaborative environment that supports personal growth and global impact. To learn more about us, visit www.fortrea.com.

    Equal Opportunity Employer

    Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, gender identity, disability, or any other legally protected characteristic. We encourage all qualified individuals to apply.

    For details on how we handle your personal data, please review our Privacy Statement.

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