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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 leading global healthcare company with a legacy of over 100 years in driving change to combat serious chronic diseases. Our work, particularly in diabetes care, has transformed lives for millions of people worldwide. Our success has made us one of the 20 most valuable companies globally by market cap.

    At Novo Nordisk, we are inspired by life in all its forms, striving to help individuals live free from chronic disease. We are committed to fostering an environment where our employees’ unique skills and perspectives are celebrated, ensuring that we continue to make life-changing impacts on people’s lives.

    Department Overview: Global Safety

    The Global Safety department in Bangalore is responsible for ensuring the safety and quality of Novo Nordisk’s clinical development and marketed products. This includes managing the global reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials, investigator-sponsored trials, named patient supplies, and third-party trials. The department works to maintain patient safety and regulatory compliance throughout the lifecycle of Novo Nordisk’s products.

    The Role: Safety Operations Adviser

    Location: Global
    Department: Global Safety

    As a Safety Operations Adviser in the GS-GBS SO Safety Operations department, you will be responsible for ensuring compliance with global regulatory requirements for the collection, evaluation, and reporting of safety data. Your work will support the safe use of Novo Nordisk’s products by evaluating adverse events, ensuring consistent coding, and collaborating across teams to ensure accurate safety assessments.

    Key Responsibilities

    • Adverse Event Management:

      • Collect, evaluate, and report adverse events (AEs) and serious adverse events (SAEs) from clinical trials, clinical use, and post-marketing.
      • Perform medical evaluation of AEs and SAEs, including evaluating possible causal relationships.
      • Ensure timely and accurate reporting to relevant health authorities to avoid regulatory delays.
      • Prepare follow-up questions and consistency checks for clinical and post-marketing cases.

    • Safety Data Handling:

      • Review AE, pregnancy, and safety forms for consistency and accuracy in coding using MedDRA.
      • Participate in coding group and case handling meetings.
      • Ensure up-to-date knowledge on safety regulations through continuous learning and participation in relevant courses and meetings.

    • Project Support & Collaboration:

      • Collaborate with clinical project teams and safety meetings as needed to ensure safety requirements are met.
      • Review clinical protocols to ensure safety data is captured accurately.
      • Provide support to Data Management colleagues on product-related safety queries.

    • Compliance & Regulatory Oversight:

      • Ensure compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) in all safety-related tasks.
      • Contribute to the reconciliation process of SAEs with clinical trial databases.

    Qualifications

    • Education:

      • Postgraduate degree in Medicine (MD/MBBS), preferably with relevant experience in Pharmacovigilance.
      • 0-1 year of experience in Pharmacovigilance or a related field within the pharmaceutical industry is preferred.

    • Skills & Knowledge:

      • Good understanding of clinical pharmacology and the clinical manifestations of diseases.
      • Proficient with computer systems and databases.
      • Fluent in English (written and spoken).
      • Strong analytical, organizational, and planning skills.
      • Ability to work independently and manage projects efficiently.
      • Flexibility and strong communication skills to collaborate with various departments.
      • Knowledge of Pharmacovigilance, clinical development, and regulatory requirements is essential.

    Working at Novo Nordisk

    At Novo Nordisk, we are more than just a company; we are a community united by a shared purpose—to make life better for people with chronic diseases. We embrace the unique skills and perspectives of our employees, creating an inclusive culture that drives innovation and impact. Together, we strive to be the best company for the world, not just the best in the world.

    Application Process

    To apply for this role, please upload your CV and motivational letter via the online application portal.

    Application Deadline: 30th November 2024

    Important Disclaimer

    We have been informed of fraudulent job offers being made in the name of Novo Nordisk. These offers may request personal information or funds for training or equipment. Please be aware that Novo Nordisk will never ask for money as part of the recruitment process.

    Equal Opportunity Commitment

    At Novo Nordisk, we are committed to an inclusive recruitment process and equal opportunities for all applicants. We celebrate the diversity of our employees and the communities we serve, ensuring that everyone’s contributions are valued and heard. Together, we’re life-changing.

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