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    Manager, Pharmacovigilance

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    3+ 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: Pharmacovigilance Manager

    Location: Sofia, Bulgaria (Office-based)
    Company: ICON plc

    About ICON plc

    ICON plc is a global leader in healthcare intelligence and clinical research. Our mission is to accelerate drug and device development, enhancing patient outcomes and quality of life. We are proud of our inclusive environment, driving innovation and fostering excellence.

    Job Summary

    The Pharmacovigilance Manager oversees personnel within the Pharmacovigilance department, ensuring compliance with company policies, regulatory requirements, and industry practices. This role involves managing resources, driving process improvements, supporting team development, and collaborating across functions to maintain quality and efficiency in pharmacovigilance services.

    Key Responsibilities

    Team & Resource Management:

    • Oversee direct reports and monitor project profitability, goals, and objectives.
    • Develop and implement metrics to evaluate team and project performance.
    • Manage resources and provide projections to align with client needs and contractual obligations.
    • Build and lead technical teams to deliver critical tasks efficiently.

    Process Improvement & Oversight:

    • Identify and implement process improvements for enhanced efficiency and compliance.
    • Provide technical oversight for project-specific plans, such as Safety Management Plans (SMP) and SAE Reconciliation Plans.
    • Maintain up-to-date knowledge of industry practices and regulatory requirements affecting pharmacovigilance services.
    • Support audit preparation, respond to findings, and ensure adherence to quality management systems (QMS).

    Team Development & Training:

    • Deliver training on pharmacovigilance and company processes to staff.
    • Foster a learning environment encouraging career development and self-improvement.
    • Provide mentorship, set goals, and offer performance feedback for team members.
    • Participate in recruiting processes to build a high-performing team.

    Client Interaction & Business Development:

    • Engage with clients to maintain relationships and secure new business opportunities.
    • Participate in business development initiatives, including presentations and proposal development.
    • Support the preparation of Standard Response Letters and other client deliverables.

    Operational Excellence:

    • Review and approve project tasks performed by pharmacovigilance staff.
    • Ensure compliance with company SOPs, policies, and client requirements.
    • Perform metric collection and data analysis to support continuous improvement initiatives.

    Requirements

    • Education: Bachelor’s degree (or higher) in a healthcare-related or life sciences field.
    • Experience:
      • At least 3 years as a Pharmacovigilance Manager in a CRO or BPO setting.
      • Strong knowledge of safety requirements across clinical development stages (pre-clinical to post-marketing).
    • Skills:
      • Strong leadership and project management abilities.
      • Analytical mindset with attention to detail.
      • Excellent English communication skills.

    Why Join ICON?

    Career Development:

    • Continuous learning culture with opportunities for growth.
    • Engaging work that adds value to your professional development.

    Comprehensive Benefits Package:

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

    Diversity & Inclusion:

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

    Reasonable Accommodations:

    • We support accommodations for medical conditions or disabilities during the application process and employment.

    Interested?

    Even if you don’t meet all requirements, we encourage you to apply! We value potential and diverse perspectives.

    Current ICON Employees: Click here to apply.

    Visit our Careers Site to explore additional opportunities and learn more about ICON.

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