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    Senior Pharmacovigilance Associate

    Icon Plc
    3-4 years
    Not Disclosed
    Remote, USA
    10 May 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    JOB DESCRIPTION

    Organization: ICON Clinical Research

    Position: Senior Pharmacovigilance Associate

    About the Role

    Overview: As a Senior Pharmacovigilance Associate, you will join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.

    Responsibilities

    Primary Duties:

    • Perform case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically-related project information, including adverse events of special interest, clinical endpoints, medical information inquiries, literature surveillance, and data retrievals from the safety database.
    • Support the generation of aggregated safety reports and Data Monitoring Committees (DMC) reviews.
    • Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing of safety events and medical information inquiries.
    • Complete all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.
    • Collaborate with Data Management to reconcile SAEs between clinical and safety databases.

    For ICON Strategic Solutions:

    • Serve as safety reporting or safety reporting intelligence processor and/or lead for multiple stand-alone projects, providing management support as designated.
    • Responsible for safety reporting or safety reporting intelligence activities on assigned projects with a customer-focused approach and an audit and inspection-ready mindset.
    • Demonstrate skills in client management, safety reporting intelligence, project scope, submission compliance, quality, and budget as designated.
    • Perform or supervise periodic reconciliation of adverse event and/or quality complaint cases within required deadlines.
    • Submit safety reports to licensing partners of ICON PRA clients.
    • Code Adverse Events according to the applicable standard dictionary.
    • Perform or supervise quality complaint activities for assigned projects, including monitoring of returning samples for quality complaints and applicable tracking.
    • Conduct Quality Control of activities as applicable.

    Qualifications

    Professional Experience:

    • 3-4 years of experience in pharmacovigilance or related field.

    Skills:

    • Proficiency in English.
    • Strong attention to detail and commitment to quality.
    • Effective communication and organizational skills.

    Why ICON?

    Rewards and Benefits:

    • Comprehensive and competitive total reward package.
    • Excellent base pay and a wide range of variable pay and recognition programs.
    • Best-in-class employee benefits, supportive policies, and wellbeing initiatives tailored to support you and your family at all stages of your career.

    Employee Development:

    • Continuous learning culture.
    • Engaging work that adds to your professional development.
    • Commitment to developing employees' knowledge, capabilities, and quality.

    Equal Opportunity Statement

    ICON, including its subsidiaries, is an equal opportunity and inclusive employer. We are committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Accommodation: If you need a reasonable accommodation due to a medical condition or disability for any part of the application process or to perform the essential functions of a position, please let us know.

    Encouragement: Interested in the role but unsure if you meet all the requirements? We encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for at ICON, whether for this or other roles.

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