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    Pharmacovigilance Assistant I

    Icon Plc
    0-5 years
    Not Disclosed
    Chennai
    10 May 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Regulatory Affairs Associate (Remote)

    Company: ICON

    About ICON: ICON is dedicated to advancing and improving patients’ lives through a diverse team and a culture of accountability, collaboration, partnership, and integrity. They strive to be the partner of choice in drug development, driven by their vision to deliver excellence to clients and patients at every touch-point.

    Key Responsibilities:

    Business Support:

    • Receive and distribute incoming safety notifications to appropriate project teams or sponsor contacts.
    • Initiate actions to protect data privacy.
    • Maintain data entry for Serious Adverse Events (SAEs) and tracking logs.
    • Prepare and submit courier shipments and electronic safety submissions.
    • Manage case tracker and distribute safety-related documents.
    • Upload documents into electronic Trial Master File (eTMF) and track status.
    • Perform translation management process.
    • Test SAE Hotline and departmental communication channels.
    • Maintain calendars, complete monthly metrics, and perform offsite archiving activities.
    • Adhere to company policies and procedures, flagging errors/non-conformance.

    Project Management Support:

    • Organize project team and client meetings.
    • Organize, review, and manage project-specific information and material.
    • Support Project Manager with financial tasks, purchase orders, and invoices.
    • Act as gatekeeper for eTMF and project files.
    • Maintain training matrix and track compliance.
    • Coordinate and access project Enterprise Document and Content Management Systems (EDCMS).
    • Monitor project team’s approved Curriculum Vitae (CV) dates.
    • Update project metrics and team members.

    Benefits of Working in ICON:

    • Competitive salary packages benchmarked against competitors.
    • Annual bonuses reflecting performance goals.
    • Range of health-related benefits for employees and families.
    • Competitive retirement plans and life assurance.
    • Encouragement to fulfill purpose and drive lasting change.

    Equal Opportunity Statement: ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Application Form: Reasonable Accommodation Form 

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