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    Senior Pharmacovigilance Reporting Associate

    Icon
    3+ years
    Not Disclosed
    Mexico
    10 July 31, 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

    About the Role

    ICON plc is a leading healthcare intelligence and clinical research organization, advancing clinical research from molecule to medicine. We provide outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. Our mission centers around patients, aiming to accelerate the development of drugs and devices that save lives and enhance quality of life.

    At ICON, our people are our greatest asset, driving our culture and success. Our team is dedicated to excellence and embodies a mission-driven spirit that ensures we excel in all we do.

    Job Summary

    • Safety Reporting Management: Serve as a safety reporting or safety reporting intelligence processor and/or lead for multiple projects, providing management support as needed.
    • Commitment to Excellence: Adhere to ICON's values, focusing on People, Clients, and Performance, and contribute to a culture of process improvement and efficiency.
    • Project Compliance: Complete all project activities accurately, following ICON SOPs, Study Specific Procedures, regulatory requirements, and client processes.
    • Customer Focus: Manage safety reporting or intelligence activities with a focus on client satisfaction, audit readiness, and compliance with submission timelines.
    • Client Management: Develop skills in client management, safety reporting intelligence, project scope, submission compliance, quality, and budget management.

    Responsibilities (Reporting)

    • Report Submission: Manage the submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings, and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, partners, and ICON personnel as required.
    • Safety Intelligence: Release safety reporting intelligence for expedited and periodic reports within specified timelines.
    • System and SOP Understanding: Maintain comprehensive knowledge of ICON's safety reporting systems, processes, conventions, and relevant SOPs, WPs, and guidance documents.
    • Project Oversight: Ensure all ICON, Sponsor, and regulatory deadlines are met for safety information reporting or global safety reporting intelligence.
    • Team Leadership: Operate in a lead capacity, taking ownership and accountability for safety reporting activities or intelligence on assigned projects.
    • Quality and Compliance: Support the Safety Reporting Group management in quality and compliance metrics review, finance tracking, resource tracking, client engagement, training, and CAPA oversight.
    • Collaboration: Work closely with project team members, client contacts, investigators, adverse event reporters, and third-party vendors to build and maintain good relationships.
    • Database Management: Maintain project information or Pharmacovigilance intelligence information with timely updates.
    • Documentation and Audit Readiness: Ensure quality control of documents and file readiness for audits or inspections.
    • Coaching and Mentoring: Mentor less experienced associates in all aspects of safety reporting or safety reporting intelligence.
    • Routine Project Activities: Coordinate routine project activities, including presentations at client or investigator meetings, response to stakeholders, and review of project requirements and metrics.
    • Client and Internal Meetings: Represent the Safety Reporting department in client and internal meetings, maintaining an understanding of applicable therapeutic areas and disease states.

    Requirements

    • Industry Experience: Experience in a Pharmaceutical/CRO environment.
    • Pharmacovigilance Expertise: At least 3 years of experience in the pharmacovigilance area.
    • Communication Skills: Excellent verbal and written communication skills, fluent in English.
    • Organizational Skills: Detail-oriented with strong organizational and time management abilities.
    • Teamwork: Ability to work effectively both independently and within global teams.

    Benefits of Working at ICON

    At ICON, we prioritize a culture that rewards high performance and nurtures talent. We offer competitive salary packages, regularly benchmarked against industry standards, with annual bonuses tied to performance goals. Our benefits include comprehensive health-related offerings for employees and their families, competitive retirement plans, and life assurance, providing confidence for the future.

    Beyond compensation and benefits, ICON offers an environment that encourages you to fulfill your sense of purpose and drive lasting change. We are committed to providing a workplace free of discrimination and harassment, ensuring equal opportunities for all applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    If you need a reasonable accommodation due to a medical condition or disability, please let us know.

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