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    Regional Pharmacovigilance Lead

    Argenx
    2+ years
    Not Disclosed
    Boston Remote, USA
    10 Nov. 5, 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: Regional Pharmacovigilance Lead
    Location: Remote (with regional focus)
    Company: argenx

    About Argenx

    Argenx is a global immunology company committed to transforming the treatment of autoimmune diseases. We are pioneering new therapies that empower patients to regain control of their lives, focusing on breakthrough medicines that address severe autoimmune conditions. Our lead product, VYVGART, is a first-in-class neonatal Fc receptor blocker, approved for the treatment of generalized myasthenia gravis (gMG), with the potential to impact dozens of other serious autoimmune diseases.

    As we expand and innovate across all areas of our business, we remain rooted in our commitment to science and patient-centered care. Argenx is a place where we inspire each other, our partners, and the communities we serve, as we advance groundbreaking science and deliver life-changing therapies.

    Role Overview

    Argenx is seeking a Regional Pharmacovigilance Lead to join our team as a scientific expert in pharmacovigilance, responsible for ensuring safety compliance and the implementation of pharmacovigilance processes in assigned regions. This individual will act as the key point of contact for pharmacovigilance within the region, manage relationships with local regulatory authorities, and contribute to the development of new processes to enhance safety reporting and compliance.

    Key Responsibilities

    Leadership & Regional Oversight:

    • Act as the primary point of contact for pharmacovigilance within the assigned countries/region.
    • Develop, establish, and maintain region-specific pharmacovigilance systems and ensure alignment with global safety standards.
    • Promote awareness and ensure compliance with pharmacovigilance obligations in the region.
    • Lead the preparation of Pharmacovigilance Agreements (PVAs) and collaborate with relevant departments to ensure proper documentation and adherence to safety regulations.

    Collaboration & Stakeholder Engagement:

    • Partner with other functions such as regulatory, medical, quality, legal, and communications to enhance safety and compliance processes.
    • Engage in local regulatory interactions and provide safety-related insights throughout the product lifecycle.
    • Lead due diligence activities as required for business partnerships and collaborations within the region.
    • Develop strong cross-functional relationships to improve adverse event reporting and pharmacovigilance operations.

    Regulatory & Compliance Management:

    • Stay updated on local and global pharmacovigilance regulations, guiding internal teams and external partners on requirements.
    • Conduct safety audits and lead inspection readiness activities in partnership with the Global Pharmacovigilance and Quality teams.
    • Contribute to the development of Key Performance Indicators (KPIs) related to pharmacovigilance in the region, ensuring performance standards align with company and regulatory expectations.

    Continuous Improvement & Education:

    • Drive continuous improvement initiatives within the region, identifying opportunities to streamline processes and enhance safety reporting.
    • Educate internal stakeholders and cross-functional teams on evolving pharmacovigilance requirements and best practices.
    • Lead training initiatives to raise awareness and improve the region’s overall understanding of safety and regulatory needs.

    Skills & Competencies

    • Communication: Excellent presentation and communication skills with the ability to distill complex information clearly.
    • Project Management: Strong planning, organizational, and multitasking skills to manage competing priorities.
    • Collaboration: Ability to influence and collaborate effectively with multidisciplinary teams.
    • Problem-Solving: Critical thinking and conflict resolution skills to address challenges in real-time.
    • Adaptability: Ability to work independently and in a global environment, maintaining flexibility to address dynamic needs.
    • Technical Expertise: Proficiency in Microsoft Office Suite and other relevant tools for safety data management.

    Education, Experience & Qualifications

    • Education: Master’s degree in Pharmacy, Nursing, Healthcare, or a related life sciences field (PharmD or MD is a plus).
    • Experience: At least 5-8 years of experience in the pharmaceutical/biotech industry, with a minimum of 3 years in pharmacovigilance or drug safety.
    • Knowledge: In-depth understanding of pharmacovigilance regulations, GVP guidance, drug development processes, and GxP compliance.
    • Language: Fluency in written and spoken English.

    Why Argenx?

    At Argenx, we are committed to building an inclusive and diverse workforce. As part of our team, you will benefit from:

    • Competitive Compensation & Benefits: We offer attractive salary packages and comprehensive health benefits.
    • Growth Opportunities: Argenx encourages professional development and continuous learning.
    • Global Impact: Join a company that is shaping the future of immunology and changing the lives of patients globally.
    • Inclusive Environment: We are an equal opportunity employer, providing a welcoming and inclusive work environment for all employees.

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