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    Pharmacovigilance Associates/Senior Associates

    Parexel
    1+ years
    Not Disclosed
    Mexico
    10 July 25, 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, 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 This Role

    Company: ICON plc
    Position: Associates and Senior Associates, Pharmacovigilance Safety & Reporting Group

    ICON plc is a global leader in healthcare intelligence and clinical research, committed to advancing clinical research from molecule to medicine. We partner with pharmaceutical, biotechnology, medical device, and public health organizations to accelerate the development of life-saving drugs and devices. At ICON, our patients are at the heart of everything we do, and our people are our greatest asset, driving our success through their dedication and passion.

    Key Responsibilities:

    Safety:

    • Process various safety events, manage medical information calls, and handle other project-related medical information.
    • Perform reconciliation of Serious Adverse Events (SAEs), conduct literature surveillance, and retrieve data from safety databases. Support the creation of aggregated safety reports and reviews for Data Monitoring Committees (DMC).
    • Ensure compliance with ICON, Sponsor, and regulatory timelines for processing and reporting safety information.
    • Assist in the accurate completion of departmental project activities according to ICON standards, regulatory requirements, and Sponsor contracts.

    Additional Responsibilities for ICON Strategic Solutions:

    • Act as a processor or lead for safety reporting or safety reporting intelligence projects, providing management support as needed.
    • Manage safety reporting or safety reporting intelligence activities on assigned projects, maintaining a customer-focused approach and readiness for audits and inspections.
    • Demonstrate skills in client management, safety reporting, project scope, submission compliance, quality assurance, and budgeting.
    • Code adverse events according to standard dictionaries.
    • Process quality complaints for assigned projects and oversee the return of samples for quality complaints, ensuring proper tracking.
    • Conduct follow-up for adverse event or product quality complaint cases in writing or by phone as required.

    Reporting:

    • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and relevant safety information to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and ICON personnel within project-specific timelines.
    • Release safety reporting intelligence for expedited and periodic reports in accordance with company procedures.
    • Maintain a thorough understanding of ICON's safety reporting systems, processes, and conventions.
    • Oversee assigned projects to ensure compliance with ICON, Sponsor, and regulatory reporting requirements.
    • Provide support to the Safety Reporting Group management in various aspects of departmental activities, including quality and compliance reviews, financial tracking, project resource tracking, client engagement, training, and CAPA oversight.
    • Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors to build and maintain positive relationships.
    • Work within multiple databases, ensuring timely updates and quality control of project and pharmacovigilance intelligence information.
    • Prepare for and represent the department in audits and inspections as required.
    • Review regulatory and safety reporting intelligence to stay informed about current regulations, practices, procedures, and proposals.
    • Mentor and coach less experienced associates in safety reporting or safety reporting intelligence activities.

    Requirements:

    • Experience in a Pharmaceutical or CRO environment
    • At least 1 year of experience in pharmacovigilance
    • Excellent verbal and written communication skills
    • Detail-oriented with strong organizational and time management skills
    • Fluency in written and verbal English
    • Ability to work effectively both independently and within a global team environment

    Benefits:

    • Competitive salary packages benchmarked regularly against industry standards
    • Annual bonuses reflecting performance goals
    • Comprehensive health-related benefits for employees and their families
    • Competitive retirement plans, including life assurance
    • Supportive work environment encouraging personal and professional growth

    ICON is committed to providing an inclusive and equal opportunity workplace, free from discrimination and harassment. We encourage all qualified applicants to apply, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you require a reasonable accommodation due to a medical condition or disability, please contact us for assistance with the application process or to perform essential job functions.

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