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    Safety Surveillance Adviser I

    Novo Nordisk
    2+ years
    Not Disclosed
    Bangalore
    10 Nov. 22, 2024
    Job Description
    Job Type: Full Time Education: MBBS/MD Skills:

    About Novo Nordisk

    Novo Nordisk is a global leader in healthcare, driven by a 100-year legacy of transforming chronic disease care. With a robust commitment to improving patient outcomes, we touch the lives of over 40 million patients daily, propelled by the passion and collaboration of over 63,000 employees worldwide. Join us to make a significant impact—together, we’re life-changing.

    Department Overview: Global Safety - Global Business Services (GS-GBS)

    Established in 2010, GS-GBS is a central hub for safety case processing and pharmacovigilance activities. The department handles a broad spectrum of responsibilities, including:

    • Case processing for spontaneous, literature, solicited, and clinical trial sources.
    • Medical review and safety report submissions.
    • Signal detection, risk mitigation, and aggregate management.
    • Configuration and maintenance of safety systems like Argus.
    • Literature surveillance, training coordination, and quality assurance.

    Our mission is to uphold the highest safety standards across Novo Nordisk’s drug development and lifecycle management.

    Position: Safety Surveillance Adviser

    Location: Bangalore, India
    Department: Global Safety - Global Business Services (GS-GBS)

    As a Safety Surveillance Adviser, you will play a critical role in establishing and maintaining the safety profiles of Novo Nordisk products throughout their lifecycle, ensuring compliance with global regulatory standards and safeguarding patient well-being.

    Key Responsibilities

    1. Product Safety Profile Management:

      • Establish and maintain the evolving Company Core Data Sheet (CCDS) for development products.
      • Manage safety-related updates to labelling for marketed products and review Labelling Change Requests (LCR).

    2. Safety Reporting and Documentation:

      • Author and prepare sections for Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), clinical Risk Management Plans (RMPs), and other regulatory documents.
      • Respond to safety-related inquiries from health authorities (HAs) and internal Novo Nordisk affiliates.

    3. Clinical Safety Oversight:

      • Provide safety input to protocols, trial outlines, Clinical Trial Reports, Investigator’s Brochures (IBs), and other clinical trial documents.
      • Support and participate in cross-functional safety committees, presenting ongoing safety analyses and recommendations.

    4. Proactive Communication and Training:

      • Deliver investigator training and provide proactive safety communication in project and trial teams.
      • Respond to safety-related queries from Ethics Committees (ECs) and ensure compliance with patient safety guidelines.

    5. Collaboration with Data Monitoring Committees (DMCs):

      • Establish deliverables to and from DMCs and provide timely responses to their inquiries.

    Qualifications

    • Educational Background:

      • Master’s degree in Medicine (MD) post-MBBS is preferred.

    • Experience:

      • Relevant expertise in Signal Management, Aggregate Management, and Individual Case Safety Reports (ICSR).

    • Skills:

      • Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
      • Analytical and detail-oriented mindset with a strong focus on quality.
      • Excellent communication and cross-cultural awareness.
      • Ability to adapt to changes in a dynamic work environment.

    Working at Novo Nordisk

    At Novo Nordisk, you will experience an inclusive and dynamic work culture that fosters growth and innovation. We empower our employees to make meaningful contributions while providing opportunities to develop both personally and professionally.

    Join us to shape a healthier future—together, we go further.

    Application Process

    • How to Apply: Submit your application, including your CV and motivational letter, through our online portal (click Apply and follow the instructions).
    • Deadline: 30th November 2024

    Important Disclaimer

    Be cautious of fraudulent job offers claiming to represent Novo Nordisk. We do not request personal information, payments, or fees as part of the recruitment process. Always verify job offers through official Novo Nordisk channels.

    Commitment to Diversity and Inclusion

    At Novo Nordisk, we aspire to be the best company for the world. We celebrate diversity and inclusivity, fostering a culture that reflects the unique perspectives of our employees, patients, and communities. Join us in making a meaningful difference—together, we’re life-changing.

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