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    Associate Safety Operations Adviser

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

    About Novo Nordisk

    Novo Nordisk is a global leader in life sciences, dedicated to defeating diabetes and other serious chronic diseases. With over 100 years of experience, we are committed to improving the lives of millions through innovative biological medicines and groundbreaking research. Our employees are driven by a shared mission to deliver life-saving treatments and make a meaningful impact on global health. At Novo Nordisk, life is our reason to exist, and we work relentlessly to help people live free from chronic disease.

    Department Overview: Global Safety

    The Global Safety department in Bangalore plays a pivotal role in ensuring the safety and quality of Novo Nordisk’s clinical development and marketed products. The team is responsible for global surveillance and reporting of adverse events, both from clinical trials and marketed product use. With a focus on compliance, medical evaluation, and global regulatory requirements, Global Safety ensures the timely and accurate handling of safety data, contributing to the continued success of Novo Nordisk products worldwide.

    Position: Safety Operations Adviser

    Location: Bangalore
    Department: Global Safety

    As a Safety Operations Adviser within the GS-GBS SO Safety Operations department, you will be responsible for ensuring the collection, evaluation, and reporting of safety information related to Novo Nordisk’s pharmaceutical products. This includes adverse event reports, serious adverse events (SAEs) from clinical trials, and investigator-sponsored trials. Your role will require strong decision-making skills, flexibility, and close collaboration with various internal and international stakeholders to ensure the medical evaluation and reporting of adverse events are consistent and compliant with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards.

    Key Responsibilities

    • Safety Data Collection & Evaluation:
      • Ensure global compliance in the collection, medical evaluation, and reporting of adverse events related to Novo Nordisk’s products.
      • Evaluate and assess the medical interpretation and causal relationships of adverse events reported globally.
      • Ensure timely reporting of serious adverse events (SAEs) to relevant authorities, in compliance with regulatory requirements.
    • Case Handling & Follow-up:
      • Perform medical reviews and evaluations for all adverse event cases, both clinical and post-marketing.
      • Prepare relevant follow-up questions, ensure consistency in the handling of clinical and post-marketing cases, and escalate critical issues to the line manager or Safety Surveillance Adviser.
    • Collaboration & Compliance:
      • Collaborate with clinical project groups, safety meetings, and other internal teams to ensure accurate safety data capture in clinical trials.
      • Ensure adherence to MedDRA coding for adverse events and prepare consistent follow-up questions.
      • Participate in the GS MedDRA Coding Group and Case Handling meetings as required.
    • Continuous Learning & Improvement:
      • Stay updated on regulatory guidelines and literature to ensure knowledge is current and relevant.
      • Participate in relevant training and conferences to maintain up-to-date knowledge of pharmacovigilance and clinical development.

    Qualifications

    • Education:
      • Postgraduate MD or MBBS with relevant pharmacovigilance experience (preferably 0–1+ years in the pharmaceutical industry).
    • Skills & Experience:
      • Solid understanding of diseases, their clinical manifestations, treatment options, and complications.
      • In-depth knowledge of clinical pharmacology and adverse event reporting processes.
      • Familiarity with computer systems and databases, especially in the pharmacovigilance context.
      • Fluent in English, both written and spoken, with excellent communication skills.
      • Strong analytical, organizational, and project management skills, with an ability to work independently.
    • Additional Skills:
      • Flexibility and the ability to work collaboratively with internal and external stakeholders.
      • Understanding of clinical development and regulatory requirements related to pharmacovigilance.

    Working at Novo Nordisk

    At Novo Nordisk, we are driven by a mission to improve the lives of patients worldwide. We believe that life is the cornerstone of everything we do, and we are committed to making a meaningful difference. Our employees are at the heart of our success, and we provide an inclusive, collaborative, and innovative environment for all. Together, we are working to help people live free from chronic diseases and transform global healthcare.

    Application Process

    To apply, please submit your CV online via our application portal.

    Deadline: 30th November 2024

    Important Disclaimer

    We have received reports of fraudulent job offers purporting to be from Novo Nordisk. These offers may request personal information or funds. Please be aware that Novo Nordisk never extends unsolicited job offers or asks for money as part of the recruitment process.

    Commitment to Diversity and Inclusion

    At Novo Nordisk, we are committed to creating an inclusive culture that celebrates diversity and offers equal opportunities to all applicants. We recognize that the success of our business depends on the talents and diverse perspectives of our employees. Together, we are life-changing.

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