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    Manager, Pharmacovigilance

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    5+ years
    Not Disclosed
    Remote, USA
    10 Nov. 21, 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: Manager, Pharmacovigilance

    Company: ICON plc

    Location: [Insert Location]

    Job Overview:
    ICON plc is a world-leading healthcare intelligence and clinical research organization. We are currently seeking a Manager, Pharmacovigilance to join our dynamic team. In this role, you will oversee pharmacovigilance activities throughout the lifecycle of clinical trial products, ensuring safety, compliance with regulatory guidelines, and fostering a culture of quality within the organization.

    Key Responsibilities:

    • Leadership: Lead the pharmacovigilance team in the collection, evaluation, and reporting of adverse events, ensuring compliance with global regulatory guidelines and internal standards.
    • Process Development: Develop and implement pharmacovigilance processes, policies, and best practices to optimize the efficiency and effectiveness of safety monitoring activities.
    • Collaboration: Work closely with clinical, regulatory, and quality assurance teams to conduct comprehensive safety assessments and ensure timely reporting of safety data.
    • Training and Guidance: Provide training and mentorship to team members, stakeholders, and external partners on pharmacovigilance regulations, practices, and procedures.
    • Safety Monitoring: Monitor safety data trends, prepare risk assessments, and present findings to relevant stakeholders, ensuring all activities are conducted according to regulatory requirements and internal quality standards.

    Requirements:

    • Education: A Bachelor’s degree in life sciences, pharmacy, or a related field is preferred.
    • Experience: Extensive experience in pharmacovigilance or drug safety management, with proven expertise in managing teams and safety activities.
    • Regulatory Knowledge: Strong understanding of regulatory requirements and safety reporting standards.
    • Analytical Skills: Ability to assess safety data and prepare safety reports for regulatory submission.
    • Leadership: Exceptional leadership and organizational skills, with the ability to manage multiple projects in a fast-paced environment.
    • Communication: Excellent communication and interpersonal skills for effective collaboration with cross-functional teams and external stakeholders.
    • Attention to Detail: A detail-oriented, proactive approach with a commitment to maintaining the highest safety and quality standards in pharmacovigilance operations.

    What ICON can offer you:

    ICON provides a comprehensive and competitive total reward package, which includes:

    • Health Insurance: A range of health insurance offerings to suit you and your family’s needs.
    • Retirement Planning: Competitive retirement offerings to help you plan with confidence for the future.
    • Employee Assistance Program: 24/7 access to a global network of professionals through LifeWorks.
    • Additional Benefits: Life assurance, annual leave entitlements, childcare vouchers, gym memberships, health assessments, and more.

    Why ICON?

    At ICON, we believe that diversity, inclusion, and belonging are key to our culture. We are committed to creating a workplace free from discrimination and harassment, offering equal opportunities to all qualified applicants. Our diverse workforce fosters innovation and helps us better serve our clients, patients, and communities.

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