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    Vigilance Compliance Excellence Manager

    Novartis
    4-7 years years
    Preffered by Company
    Hyderabad
    10 July 9, 2024
    Job Description
    Job Type: Full Time Education: Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Vigilance Compliance Excellence Manager

    Job ID: REQ-10008948
    Posted On: June 27, 2024
    Location: Hyderabad, India
    Division: Development
    Business Unit: Innovative Medicines
    Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
    Functional Area: Research & Development
    Job Type: Full-time
    Employment Type: Regular
    Shift Work: No

    Summary

    The Vigilance Compliance Excellence Manager is responsible for developing and implementing new monitoring activities and metrics for safety case management, aggregate reporting, and risk management plan processes. This role also involves assessing and adapting established metrics in response to changes in the regulatory and Novartis environment, managing the completion of monitoring activities, and producing metrics.

    Major Accountabilities

    • Metrics Development: Develop and implement compliance and quality metrics for new safety case management, aggregate reporting, and risk management plan processes in collaboration with process/metrics owners, QA, and other global line functions.
    • Tool Development: Develop and maintain tools with Innovation, Tech & Systems, and other Global Line Functions to monitor compliance and quality, introducing automation where possible.
    • Training and Communication: Develop and implement training materials and communications.
    • Regulation Compliance: Review emerging worldwide regulations, perform impact assessments, and drive necessary process changes to ensure ongoing compliance with global regulatory requirements.
    • Regulation Implementation: Ensure timely implementation of changes required by new regulations/health authority’s guidance.
    • Procedural Documents: Develop and maintain procedural documents, including ownership of relevant PSMF sections and annexes.
    • Feedback Integration: Review and integrate feedback from Health Authorities or other external parties into Novartis group standards.
    • Audit Support: Act as a subject matter expert during audits and inspections (e.g., FDA and EMA), lead preparation of responses to findings, and develop and implement CAPAs.
    • Monitoring and CAPAs: Lead investigations into identified deficiencies, develop and implement corrective and preventative actions (CAPAs), and measure their effectiveness.
    • Collaboration: Collaborate with other Global Line Functions across Novartis Divisions and Third Parties to establish and meet joint accountabilities.
    • Risk Escalation: Ensure risks identified through metrics data analysis are escalated appropriately to the Operational Metrics and Risk Committee, PS&PV leadership, and other global line functions or External Service Providers (ESPs).
    • External Representation: Represent Novartis externally as a subject matter expert.
    • Best Practice Sharing: Share best practices regarding metrics methodologies and mentor associates to develop a stronger understanding of compliance and quality metrics.
    • Support in Mergers and Acquisitions: Act as a business representative during mergers and acquisitions.
    • Training and Mentorship: Train and mentor new PS&PV associates and associates from other global line functions.

    Minimum Requirements

    • Experience: Minimum 4 to 7 years in the pharmaceutical industry, particularly in pharmacovigilance.
    • Skills:
      • Project management experience and ability to lead working groups in a matrix environment.
      • Strong organizational skills.
      • Strong negotiation, presentation, and communication skills.
      • Ability to interact with a wide variety of people at all levels.
      • Strong analytical skills and quality focus.

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