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    Senior Manager, Pharmacovigilance

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    1+ years
    Not Disclosed
    Bulgaria
    10 Nov. 23, 2024
    Job Description
    Job Type: Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Location: Not specified
    Company: ICON plc

    About ICON plc

    ICON plc is a global leader in healthcare intelligence and clinical research. With a mission to improve patient outcomes, we collaborate with pharmaceutical, biotechnology, medical device, and government organizations to accelerate drug and device development. At ICON, our people are our greatest strength, driving success through innovation and passion.

    Job Summary

    The Senior Manager, Pharmacovigilance, is responsible for overseeing pharmacovigilance projects to ensure profitability, efficiency, and compliance with regulatory and client requirements. This role serves as the primary point of contact for assigned projects, providing leadership and technical expertise while fostering team development and ensuring high-quality deliverables.

    Key Responsibilities

    Project & Resource Management:

    • Monitor projects to ensure profitability and alignment with goals.
    • Serve as the main pharmacovigilance point of contact for standalone and full-service projects.
    • Analyze project backlog to allocate adequate resources.
    • Provide technical oversight for Safety Management Plans (SMP) and SAE Reconciliation Plans.

    Process Improvement & Oversight:

    • Identify and implement process improvements for efficiency and compliance.
    • Review SOPs and recommend updates to senior management.
    • Ensure team adherence to company and client QMS, SOPs, and regulatory guidelines.

    Team Development & Leadership:

    • Foster an environment of learning and career development.
    • Deliver training on pharmacovigilance and company systems to staff.
    • Provide mentorship, performance feedback, and support for career advancement.
    • Participate in the recruitment and onboarding of new employees.

    Client & Business Development:

    • Build and maintain client relationships to secure repeat business.
    • Participate in business development initiatives, including proposal preparation and presentations.
    • Act as a Subject Matter Expert (SME) in pharmacovigilance processes and technologies.

    Operational Excellence:

    • Coordinate interdepartmental activities, such as quality assurance and control processes.
    • Represent pharmacovigilance in global initiatives and industry events.
    • Deliver training to internal and external stakeholders, including clients and investigators.
    • Ensure timely responses to audits and support compliance efforts.

    Industry Engagement:

    • Represent ICON through presentations at conferences, articles in industry publications, or obtaining certifications.

    Requirements

    • Thorough knowledge of global and local medical device health authority regulations, ICH guidelines, and policies.
    • Strong project management skills and the ability to operate autonomously.
    • Effective planning, organizational, and leadership skills.
    • Experience with client interactions and relationship management.
    • Highly motivated, proactive, and skilled in team scaling and structuring.

    Benefits of Working at ICON

    Career Growth:

    • A continuous learning culture with opportunities for professional development.

    Comprehensive Benefits Package:

    • Competitive salary with variable pay and recognition programs.
    • Flexible health insurance options for you and your family.
    • Retirement planning programs for long-term financial security.
    • Generous annual leave entitlements.
    • Access to the Global Employee Assistance Programme (LifeWorks) for you and your family’s well-being.
    • Additional benefits like childcare vouchers, gym memberships, and health assessments.

    Diversity & Inclusion:

    • ICON values diversity, inclusion, and belonging, fostering innovation and excellence.
    • Committed to providing a workplace free of discrimination and harassment.

    Reasonable Accommodations:

    • Support provided for individuals with medical conditions or disabilities throughout the hiring process and employment.

    How to Apply

    If you’re interested but unsure if you meet all the requirements, we encourage you to apply. We’re looking for diverse talent who can contribute meaningfully to ICON.

    Current ICON Employees: Click here to apply.

    Visit our Careers Site to explore more opportunities at ICON.

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