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    Pharmacovigilance Associates/Senior Associates

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    1+ years
    Not Disclosed
    Remote, USA
    10 Sept. 17, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Job Title: Pharmacovigilance Associate

    Location: Mexico City, Mexico

    Company: ICON plc

    About Us:

    ICON plc is a leading global healthcare intelligence and clinical research organization. We are dedicated to fostering an inclusive environment that drives innovation and excellence. Join us in shaping the future of clinical development.

    Position Summary:

    We are seeking a dedicated Pharmacovigilance Associate to join our diverse and dynamic team. This role involves reviewing and processing safety events and medically related information, supporting safety management, and ensuring compliance with regulatory requirements.

    Key Responsibilities:

    • Safety Event Processing: Review and process safety events (pre-marketing, post-marketing, medical device, and drug) and other medically related information according to project-specific procedures.
    • Literature Review: Review abstracts and full articles to identify safety information from literature sources for both pre- and post-marketed products.
    • Data Management: Generate data listings from the safety database and ensure data accuracy.
    • Adverse Event Follow-up: Complete adverse event follow-ups in writing and/or by phone based on client requirements.
    • Safety Tracking: Provide input and review safety tracking systems for accuracy and quality, and maintain project files.
    • Case Processing: Perform safety reviews of clinical and diagnostic data as part of case processing.
    • Safety Management Plan: Develop and maintain the Safety Management Plan, including processes to ensure consistency within the project.
    • Post-Marketing Activities: Support post-marketing safety activities, including PSMF, RMP, and PBRER.
    • Liaison: Liaise with investigational sites, reporters, sponsors, ICON Medical Monitors, project managers, and other departments as needed.
    • Safety Reports: Assist in generating aggregated safety reports, such as Development Safety Update Reports, IND Annual Reports, Periodic Safety Update Reports, and other cumulative safety reports.
    • Data Analysis: Support interim data analysis for Data Monitoring Committee reviews.
    • Database Maintenance: Maintain the safety database and entry guidelines, ensuring data quality following established quality control processes.
    • Reconciliation: Support SAE/AE reconciliation plans and activities.
    • Signal Detection: Assist Safety Scientists in signal detection and risk management activities.
    • Audits and Inspections: Support audits and inspections as required for assigned projects.
    • Medical Inquiries: Respond to and process medical information inquiries related to adverse events and product complaints as per client agreements.

    Qualifications:

    • Experience: At least 1 year of experience in pharmacovigilance within a pharmaceutical or CRO environment.
    • Skills: Excellent verbal and written communication skills, detail-oriented, and strong organizational and time management abilities.
    • Language: Fluent in written and verbal English.
    • Work Style: Ability to work effectively both independently and as part of a global team.

    What We Offer:

    ICON values its people and offers a range of benefits designed to support your well-being and work-life balance:

    • Competitive salary
    • Various annual leave entitlements
    • Health insurance options for you and your family
    • Competitive retirement planning offerings
    • Global Employee Assistance Programme, LifeWorks, providing 24-hour support
    • Life assurance
    • Flexible benefits including childcare vouchers, bike purchase schemes, gym memberships, and more

    Diversity and Inclusion:

    ICON is an equal opportunity employer committed to providing a workplace free of discrimination and harassment. We welcome applicants regardless of 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, please let us know or submit a request here.

    Interested in This Role?

    If you are interested in this role but feel you may not meet all the requirements, we encourage you to apply anyway. You might be exactly what we’re looking for.

    Current ICON Employees:

    If you are a current ICON employee, please apply here.

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