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    Global Head Pharmacovigilance Qa

    Novartis
    10+ years
    Not Disclosed
    Switzerland
    10 Nov. 26, 2024
    Job Description
    Job Type: Full Time 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

    Pharmacovigilance Quality Assurance (PVQA) Lead
    Location: Basel, Switzerland (80-100%)
    Working Model: Hybrid (12 days/month in the office)

    About the Role
    Join the Pharmacovigilance Quality Assurance (PVQA) team within Novartis Development Quality, where you’ll provide comprehensive expertise and oversight of Pharmacovigilance (PV) Quality. This role is critical in ensuring compliance with regulations and the Novartis Quality Management System across global PV and Device Vigilance systems, as well as patient-focused commercial activities.

    Key Responsibilities:

    • Collaborate with global and local teams to oversee PV, Device Vigilance, and patient-focused activities ensuring regulatory compliance.
    • Lead quality governance for PV activities, establishing harmonized standards across global, regional, and local operations.
    • Maintain inspection readiness for Health Authority (HA) PV inspections, contributing to preparation, management, and follow-up activities.
    • Support strategic objectives, including due diligence and managing transitions for mergers, acquisitions, and divestitures.
    • Oversee Novartis PV quality systems and support updates to the Pharmacovigilance System Master File (PSMF) in compliance with regulations.
    • Manage vendor quality and drive improvement initiatives to enhance vendor performance.
    • Serve as a PV Quality representative on the Portfolio Stewardship Board, addressing safety risks and ensuring patient protection.
    • Drive continuous quality improvement through effective collaboration with stakeholders and integration into the Quality Plan.
    • Ensure robust monitoring of the Novartis PV and Device Vigilance systems, fulfilling global regulatory requirements.
    • Develop and implement measures for managing PV/Device Vigilance quality and compliance issues effectively.

    What You’ll Bring:
    Essential Qualifications:

    • Degree in Life Sciences or a related field (PhD or advanced degree preferred).
    • Minimum 10 years of experience in the pharmaceutical industry, with at least 5 years in PV, Quality Management, or GXP regulatory roles.
    • At least 3 years of global team management experience.
    • Extensive knowledge of international PV and Device Vigilance regulations (e.g., FDA/EU, ICH).
    • Proven leadership skills with experience managing diverse, cross-functional teams.
    • Strong problem-solving, negotiation, and communication abilities.

    Preferred Skills:

    • Fluent in English (written and spoken); additional languages are an advantage.
    • Expertise in areas such as inspection preparedness, risk management, and stakeholder engagement.
    • Agility, strategic decision-making, and business acumen.

    Why Novartis?
    At Novartis, we aim to improve and extend people’s lives by reimagining medicine. Join a community of innovative, passionate individuals dedicated to transforming healthcare.

    Benefits and Rewards:
    Explore our comprehensive rewards program in the Novartis Life Handbook.

    Diversity and Inclusion:
    We are committed to building inclusive teams that reflect the diversity of the patients and communities we serve.

    Stay Connected:
    If this role doesn’t align with your experience, join our Novartis Network to stay informed about future opportunities.

    Together, let’s create a brighter future.

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