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    Senior Pharmacovigilance Associate

    Icon Plc
    2+ years
    Not Disclosed
    Mexico
    10 Jan. 22, 2025
    Job Description
    Job Type: Hybrid Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Senior Pharmacovigilance Associate
    Location: Hybrid (Mexico City)
    Employer: ICON plc
    Salary: Competitive
    Start Date: January 17, 2025
    Closing Date: February 16, 2025

    About ICON plc:

    ICON plc is a leading global healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence, and we invite you to join us in shaping the future of clinical development.

    Position Overview:

    ICON is seeking a Senior Pharmacovigilance Associate to play a crucial role in ensuring the safety and efficacy of pharmaceutical products. The successful candidate will be responsible for managing and overseeing pharmacovigilance activities, collaborating with cross-functional teams, ensuring compliance with regulatory requirements, and maintaining the highest standards of patient safety.

    Key Responsibilities:

    • Adverse Event Reporting & Data Analysis:

      • Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
      • Conduct thorough analysis of safety data, identify trends, and investigate potential safety signals.

    • Regulatory Compliance & Documentation:

      • Prepare and submit periodic safety update reports (PSURs) and other regulatory documents, ensuring adherence to international regulations.
      • Collaborate with medical and clinical teams to assess adverse events and contribute to risk management activities.

    • Pharmacovigilance Database Management:

      • Oversee the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.

    • Training & Mentorship:

      • Provide training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.

    • Audit & Inspection Readiness:

      • Support audits and inspections by regulatory authorities to ensure compliance with pharmacovigilance requirements.

    • Regulatory Knowledge & Process Improvement:

      • Stay updated on evolving regulatory guidelines and industry best practices, continuously enhancing pharmacovigilance processes.

    Required Qualifications & Skills:

    • Educational Requirements:

      • Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred.

    • Experience & Expertise:

      • Extensive experience in pharmacovigilance or drug safety, with strong knowledge of relevant regulations and industry standards.
      • Proven ability to manage the pharmacovigilance process, including adverse event reporting and signal detection.
      • Proficiency in pharmacovigilance databases and data management systems.

    • Skills:

      • Strong analytical, critical thinking, and data interpretation skills.
      • Advanced English proficiency, with excellent communication and interpersonal skills.
      • Ability to manage multiple priorities and work independently in a fast-paced environment.
      • Commitment to confidentiality and the handling of sensitive patient information with discretion.

    What ICON Offers:

    • Competitive Salary & Benefits:

      • ICON offers a range of benefits focused on employee well-being and work-life balance, including:
        • Annual leave entitlements
        • Health insurance options for you and your family
        • Competitive retirement planning
        • Life assurance
        • Global Employee Assistance Programme (LifeWorks) providing 24/7 support
        • Flexible country-specific benefits (e.g., childcare vouchers, gym memberships, travel passes)

    • Career Development:

      • ICON is committed to fostering a diverse and high-performance culture and offers various development opportunities for career progression.

    Diversity & Inclusion:

    ICON believes that diversity, inclusion, and belonging are key to our culture and values. Our rich diversity drives innovation and helps us better serve our people, patients, customers, and communities. We are dedicated to providing an inclusive environment and are committed to eliminating discrimination and harassment. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    Accommodation:

    If you require a reasonable accommodation due to a medical condition or disability during the application process or to perform the essential functions of the role, please submit a request.

    Application Instructions:

    If you're interested in the role but unsure if you meet all of the requirements, we encourage you to apply regardless — you may be exactly what we're looking for.

    Current ICON employees: Please apply through the internal portal.

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