Functional Quality Specialist I - Pune - Thepharmadaily

    Thepharmadaily
    Thepharmadaily Pune

    3 days ago

    Full time
    Description

    Adverse Events and Product Quality Management:

    • Manage and review expeditable adverse events, product quality complaints, and medical information.
    • Submit reports to clients and regulatory agencies within agreed timelines.

    Process Review and Audit Readiness:

    • Assist in process reviews and measure/monitor audit readiness.
    • Coordinate client or external audits of assigned projects.

    Training and Development:

    • Design and track training schedules and materials for new hires and existing team members.

    Quality Management:

    • Contribute to quality error discussions and process improvements.
    • Assist in developing Quality Management Plans for assigned projects.
    • Support clients during regulatory inspections with the project team.

    Data Analysis and Process Improvement:

    • Perform and review data analysis to suggest and drive process improvements.
    • Track various types of information and metrics, conduct ongoing QC of defined process steps, and reconcile data from multiple sources.

    Medical Information Queries:

    • Respond to medical information queries, product quality complaints, and general queries received via telephone, email, fax, etc
    • Review recorded information and execute drug safety data management processes.

    Safety Data Management:

    • Guide safety associates in managing voice calls as required.
    • Review and drive strategies for process improvement/excellence.

    Regulatory Submissions:

    • Review safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, Clinical Study Reports, etc

    General Support Activities:

    • Perform additional support activities as assigned.

    Who We Are Seeking:

    Fortrea is looking for motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process to deliver life-changing ideas and therapies swiftly to patients in need.

    Why Join Fortrea:

    • Embrace a collaborative workspace that nurtures personal growth.
    • Make a meaningful global impact in clinical development.
    • Join an exceptional team dedicated to innovation and excellence

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