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    Senior Pharmacovigilance 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 global leader in healthcare intelligence and clinical research. We are dedicated to advancing clinical research and providing outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. Our work helps accelerate the development of drugs and devices that save lives and improve quality of life, with patients at the heart of everything we do.

    Our greatest asset is our people, who embody our culture and drive our success. At ICON, we are driven by a mission to succeed and a passion for excellence.

    Responsibilities (Safety)

    • Adverse Event Management: Review and process serious adverse events, spontaneously reported adverse reactions, and other medically relevant information according to study-specific procedures.
    • Literature Surveillance: Conduct literature reviews in designated databases as per project scope and established procedures.
    • Safety Data Tracking: Input and review safety tracking systems for accuracy and quality, maintaining project files as needed.
    • Clinical Data Review: Perform safety reviews of clinical and diagnostic data for case processing.
    • Regulatory Reporting: Assist in generating regulatory reports to ensure compliance.
    • Interdepartmental Coordination: Liaise with other ICON departments, investigational sites, reporters, and sponsors regarding safety issues.
    • Project Support: Coordinate interdepartmental activities, including listing review, quality control, quality assurance (audits), and miscellaneous project tasks.
    • Safety Management Plan Development: Develop the Safety Management Plan, including processes to ensure consistency within the project.
    • SAE/AE Reconciliation: Support the creation and execution of the SAE/AE reconciliation plan and ensure adherence to project-specific guidelines.
    • Functional Leadership: Serve as Functional Lead on case processing or medical information projects, coordinating Pharmacovigilance associates and acting as the point of contact for project teams.
    • Database Management: Maintain the safety database, ensuring data quality through established quality control processes.
    • Data Listing and Reporting: Generate and ensure the accuracy of data listings from the safety database.
    • Support in Reporting: Assist in the analysis and quality control of Aggregated Safety Reports, such as Development Safety Update Reports and Periodic Safety Update Reports.
    • Signal Detection and Risk Management: Support Safety Scientists in these activities.
    • Interim Data Analysis: Assist in interim data analysis for Data Monitoring Committee (DMC) reviews.
    • Meeting Participation: Participate in internal and client project team meetings, presenting safety processes at kick-off and investigator meetings.
    • Project Status Reporting: Report project status, including metrics, to project and functional management within agreed timelines.
    • Financial and Administrative Adherence: Manage project budgets, timelines, and resources, and estimate hours required for tasks.
    • Problem-Solving: Propose solutions for procedural and technical issues.
    • Audit Support: Provide support during audits and inspections for assigned projects.
    • Subject Matter Expertise: Act as a subject matter expert for case processing and/or medical information tasks within project teams.
    • Medical Information Management: Respond to and process medical information inquiries, including those related to adverse events/reactions and product complaints.

    Requirements

    • Industry Experience: Experience in a Pharmaceutical/CRO environment.
    • Pharmacovigilance Experience: At least 3 years of experience in pharmacovigilance.
    • 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 a team environment, including across global teams.

    Benefits of Working at ICON

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

    Beyond competitive compensation and benefits, ICON offers an environment that encourages fulfilling your sense of purpose and driving 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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