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    Senior Vigilance Process Manager

    Novartis
    6-8 years
    Not Disclosed
    Hyderabad
    10 June 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Summary

    Position: Pharmaco- and Devices Vigilance Manager
    Location: Hyderabad, India
    Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
    Division: Development
    Business Unit: Innovative Medicines
    Functional Area: Research & Development
    Job Type: Full-time
    Employment Type: Regular
    Shift Work: No

    Manage end-to-end pharmaco- and devices vigilance processes across Novartis and lead cross-functional and transformative PS&PV projects to ensure compliance with global regulatory requirements efficiently.

    Major Accountabilities

    • Process Optimization: Drive continuous process optimization and simplification by aligning relevant stakeholders globally and locally, assessing opportunities for streamlining and automation.
    • Project Leadership: Lead/support complex cross-functional and PS&PV projects, including IT projects/systems, as Senior SME.
    • Regulatory Compliance: Lead active surveillance and analysis of emerging regulations, perform impact assessments, and drive necessary process changes.
    • Documentation and Training: Develop, communicate, and maintain procedural documents and training materials. Collaborate to establish requirements for metrics trend analyses, generate knowledge, and mitigate identified risks.
    • Expert Consultation: Act as a Subject Matter Expert for PS&PV associates, Country Organizations, and other Global Line Functions on regulatory requirements and business processes.
    • Business Continuity: Maintain relevant PSMF sections, annexes, and Business Continuity Plans for respective processes, including IT applications.
    • Safety Database Management: Lead development and implementation of safety database enhancements, new safety case processing conventions, and standards for data migrations.
    • Audit and Inspection Support: Act as a subject matter expert during audits and inspections, lead response preparations, and develop corrective and preventative actions.
    • Collaboration: Lead collaboration with other Global Line Functions and Third Parties to establish and meet joint accountabilities.
    • Mergers and Acquisitions: Act as business representative during mergers, spin-offs, and acquisitions. Represent team in governance boards and cross-functional forums.
    • External Representation: Represent Novartis externally as a subject matter expert and participate in external conferences and networks.

    Minimum Requirements

    • Experience: 6-8 years in the pharmaceutical industry, particularly in pharmacovigilance; experience in medical device vigilance is desirable.
    • Leadership Skills: Proven leadership and (matrix) management experience. Ability to lead global and cross-functional work groups in a matrix environment.
    • Skills: Strong organizational, analytical, project management, negotiation, and communication skills. Ability to operate effectively in an international, matrix environment.

    Why Novartis?

    In 2021, Novartis medicines touched 766 million lives. We strive to improve and extend lives by combining medical science with digital innovation in a diverse, equitable, and inclusive environment. Our unbossed culture, underpinned by integrity, curiosity, and flexibility, allows us to tackle the world’s toughest medical challenges. Imagine what you could do at Novartis!

    Join our Novartis Network: If this role does not suit your experience or career goals, join our talent community to stay connected and learn about suitable career opportunities: Join the Novartis Network.

    Learn More About Novartis: Our Strategy, People, and Culture.

    Commitment to Diversity:

    Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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