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    Senior Medical Reviewer

    Novo Nordisk
    3-5 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 healthcare with a legacy of over 100 years in combating serious chronic diseases. With a strong focus on diabetes care, we impact the lives of over 40 million patients daily and continue to innovate across our diverse workforce of 63,000 employees worldwide. Join us in driving change and shaping the future of healthcare.

    Department Overview: Centralised Monitoring Unit (CMU)

    The Centralised Monitoring Unit (CMU) in Bangalore is a key part of the Clinical Drug Development area. The team comprises:

    1. Medical Reviewers: Focused on risk-based medical monitoring to ensure patient safety and protocol compliance.
    2. Functional Programmers: Develop data visualizations to enable proactive centralized monitoring.
    3. Statistical Monitors: Detect unusual data patterns, systematic errors, and potential compliance issues in clinical trials.

    This department ensures the safety and well-being of clinical trial participants by identifying clinically significant outliers and supporting medical data cleaning processes.

    Position: Senior Medical Reviewer

    Location: Bangalore, India
    Department: Centralised Monitoring Unit (CMU)

    As a Senior Medical Reviewer, you will conduct comprehensive medical reviews of clinical trial data across multiple therapy areas, ensuring data quality, patient safety, and compliance with Good Clinical Practice (GCP), ICH guidelines, and local regulations.

    Key Responsibilities

    • Medical Review and Monitoring:

      • Perform quality checks and comprehensive reviews of clinical trial data to identify inconsistencies or concerns.
      • Clarify and resolve medical concerns in collaboration with investigational site staff.
      • Document medical reviews in the Trial Master File (TMF).

    • Collaboration and Stakeholder Engagement:

      • Work closely with Data Managers, Trial Managers, and Medical Specialists throughout the trial process.
      • Provide timely updates on review statuses and escalate any trial-related issues.

    • Training and Process Improvements:

      • Train new team members on processes and projects.
      • Review and provide input on medical monitoring plans and data listings to enable efficient medical reviews.

    • Reporting and Presentation:

      • Present medical review findings to Medical Specialists to support decision-making.

    Qualifications

    • Educational Background:

      • Graduate degree in Medicine or a related field (MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience will also be considered).

    • Professional Experience:

      • 3-5 years of experience in Clinical Drug Development (e.g., Medical Monitoring, Investigator, Medical Data Review, etc.).
      • 1-2 years of project management experience.

    • Technical and Analytical Skills:

      • Strong knowledge of ICH guidelines, GCP principles, and clinical trial processes.
      • Proficiency in MS Office, MS Project, and PowerPoint.
      • Excellent grasp of medical terminology.

    • Language and Communication:

      • Exceptional proficiency in written and spoken English.

    Working at Novo Nordisk

    At Novo Nordisk, we foster an environment of collaboration, inclusivity, and growth. As part of our team, you will work toward a shared goal of making a meaningful difference in the lives of patients worldwide. Together, we are life-changing.

    Application Process

    How to Apply: Submit your CV through the online application portal (click Apply and follow the instructions).
    Deadline: 20th November 2024

    Important Disclaimer

    Beware of fraudulent job offers claiming to represent Novo Nordisk. We do not request personal information, payment, or training fees during the recruitment process. Always verify communications via official Novo Nordisk channels.

    Commitment to Diversity and Inclusion

    Novo Nordisk is committed to fostering an inclusive culture that celebrates diverse perspectives, backgrounds, and talents. We strive to be the best company for the world, creating opportunities for all while improving the lives of patients and communities we serve.

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