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    Senior 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: Senior Manager, Pharmacovigilance

    Company: ICON plc

    Location: [Insert location]

    Job Overview:
    ICON plc is a global leader in healthcare intelligence and clinical research. We partner with pharmaceutical, biotechnology, medical device, and government organizations to advance clinical research and improve lives. We are currently seeking a Senior Manager, Pharmacovigilance to lead and manage pharmacovigilance projects, ensuring client satisfaction and regulatory compliance. This role involves overseeing safety management plans, team development, process improvement, and business development initiatives.

    Key Responsibilities:

    • Project Management: Oversee projects to ensure company profitability and goals are met, while managing project timelines, objectives, and resources.
    • Client Interaction: Serve as the main point of contact for clients on pharmacovigilance matters for stand-alone and full-service projects, ensuring smooth communication and project delivery.
    • Team Leadership: Manage a team, providing leadership and guidance on safety reporting, SOPs, and regulatory compliance.
    • Process Improvement: Identify and implement process improvements to enhance operational efficiency and ensure the high quality of service delivery.
    • Training and Development: Deliver training on pharmacovigilance topics and company processes to both internal staff and external parties such as clients and investigators.
    • Resource Management: Allocate resources effectively to meet client needs and contractual obligations, analyzing future project needs to maintain alignment with business objectives.
    • Audits and Compliance: Support audit preparation and conduct, responding to findings and ensuring adherence to quality standards and industry regulations.
    • Business Development: Contribute to business development efforts by maintaining client relationships and supporting new business opportunities, proposals, and presentations.
    • Industry Presence: Represent ICON at industry conferences, write articles for publications, and engage in industry certifications to build ICON’s presence and leadership.

    Requirements:

    • Education: Bachelor’s degree in a healthcare-related or life science field.
    • Experience: Extensive experience in pharmacovigilance, with at least 5 years of leadership experience in a similar role.
    • Regulatory Knowledge: In-depth understanding of local and global medical device regulations, ICH Guidelines, and pharmacovigilance standards.
    • Project Management: Proven ability to manage large-scale projects, with excellent planning, organizational, and people management skills.
    • Client Management: Experience interacting with clients and managing customer relationships is highly advantageous.
    • Autonomy: Ability to make independent decisions and operate autonomously.
    • Leadership: Strong leadership abilities with a focus on team development, mentorship, and fostering a collaborative environment.

    Benefits of Working at ICON:

    ICON offers a competitive salary along with a range of employee benefits designed to support your professional and personal well-being. Some benefits include:

    • Health Insurance: Tailored plans to suit your family’s needs.
    • Retirement Planning: Competitive offerings for long-term financial security.
    • Employee Assistance Program: 24/7 access to a global network of specialists.
    • Life Assurance: Coverage for peace of mind.
    • Additional Benefits: Flexible perks such as childcare vouchers, gym memberships, and health assessments.

    Why ICON?

    At ICON, we value diversity, inclusion, and innovation. Our diverse workforce strengthens our ability to solve complex challenges and deliver results. We are committed to fostering a culture of inclusion and providing an accessible, supportive work environment for all candidates.

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