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    Senior Pharmacovigilance Associate

    Icon Plc
    0-2 years
    Not Disclosed
    Mexico Remote
    10 Jan. 21, 2025
    Job Description
    Job Type: Full Time Remote Education: B.Sc, M.Sc, B.Pharm, M.Pharm and 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
    Employer: ICON Plc
    Location: Mexico (Hybrid – Mexico City only)
    Salary: Competitive
    Start Date: 17th January 2025
    Closing Date: 16th February 2025

    About ICON Plc:

    ICON plc is a global leader in healthcare intelligence and clinical research. We are committed to fostering an inclusive and innovative environment, shaping the future of clinical development. ICON values diversity and inclusion, and we are proud to offer an inclusive workplace to our employees.

    Job Overview:

    ICON Plc is seeking a Senior Pharmacovigilance Associate to join our dynamic and diverse team. In this role, you will be responsible for managing pharmacovigilance activities, ensuring the safety and efficacy of pharmaceutical products, and collaborating with cross-functional teams to comply with regulatory requirements.

    Key Responsibilities:

    • Adverse Event Management: Lead the collection, evaluation, and processing of adverse event reports, ensuring timely and accurate reporting in compliance with regulatory guidelines and company policies.
    • Safety Data Analysis: Conduct thorough data analysis, interpret safety data, identify trends, and investigate potential safety signals.
    • Regulatory Compliance: Prepare and submit Periodic Safety Update Reports (PSURs) and other regulatory documents, ensuring adherence to international regulations.
    • Risk Management: Collaborate with medical and clinical teams to assess the clinical relevance of adverse events and contribute to risk management activities.
    • Data Integrity: Oversee the maintenance and accuracy of pharmacovigilance databases, ensuring compliance with data management standards.
    • Training & Mentorship: Provide training and mentorship to junior team members on pharmacovigilance processes, regulations, and best practices.
    • Audit & Inspections: Participate in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with pharmacovigilance requirements.
    • Continuous Learning: Stay updated on evolving regulatory guidelines and industry best practices to enhance pharmacovigilance processes.

    Required Qualifications:

    • Education: Bachelor’s degree in life sciences, pharmacy, nursing, or a related field (Advanced degree preferred).
    • Experience: Extensive experience in pharmacovigilance or drug safety with a strong understanding of relevant regulations and industry standards.
    • Skills:
      • Proven ability to manage pharmacovigilance processes effectively, including adverse event reporting and signal detection.
      • Strong analytical and critical thinking skills with the ability to interpret complex data.
      • Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.
      • Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
      • Ability to work independently, managing multiple priorities in a fast-paced environment.
      • Advanced English language skills.
      • Commitment to maintaining confidentiality and handling sensitive patient information responsibly.

    Additional Preferred Skills:

    • Experience with audit and inspection processes.
    • Ability to mentor and train junior staff.

    Benefits:

    • Competitive salary with annual leave entitlements.
    • Comprehensive health insurance options for you and your family.
    • Retirement planning benefits to help you save for the future.
    • Global Employee Assistance Program offering 24/7 support for well-being.
    • Life assurance.
    • Flexible, country-specific benefits, such as childcare vouchers, bike purchase schemes, discounted gym memberships, and more.

    For a full list of benefits, visit ICON's careers site.

    Why Join ICON?

    At ICON, we believe that the quality of our people drives our success. That’s why we’ve prioritized building a diverse and inclusive culture that rewards high performance and nurtures talent. We are committed to providing a workplace free from discrimination and harassment.

    Equal Opportunity Employer:

    ICON is an equal opportunity employer, dedicated to providing an inclusive and accessible environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Accommodation Requests:

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

    How to Apply:

    If you’re interested in this role but unsure if you meet all the requirements, we encourage you to apply. You may be exactly what we’re looking for at ICON.

    Closing Date for Applications: 16th February 2025

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