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Senior Medical Reviewer

3-5 years
Not Disclosed
10 Feb. 5, 2025
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

Job Title: Senior Medical Reviewer
Location: Bangalore, India
Department: Centralised Monitoring Unit (CMU)
Job Category: Clinical Development


About the Role

Novo Nordisk is looking for a Senior Medical Reviewer to join their Centralised Monitoring Unit (CMU) in Bangalore, India. This role involves conducting comprehensive medical reviews of clinical trial data, ensuring patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP) and international guidelines. The Senior Medical Reviewer will collaborate with various study team members and contribute to the quality and consistency of medical data across different therapy areas in the drug development portfolio.


Responsibilities

  • Medical Review: Conduct detailed medical reviews of clinical trial data across various therapy areas.
  • Collaboration: Work closely with Data Managers, Trial Managers, and Medical Specialists to ensure timely updates and resolve issues.
  • Training and Support: Provide training on the project and process to new team members.
  • Documentation: Ensure medical reviews are properly documented in the sponsor TMF (Trial Master File).
  • Data Quality: Perform quality checks for medical review and clarify any inconsistencies in clinical trial data.
  • Monitoring: Contribute to medical monitoring displays and data listings for efficient medical review.

Qualifications

  • Required:
    • Graduate degree in Medicine (MBBS & MD in Pharmacology preferred).
    • 3-5 years of relevant experience in Clinical Drug Development.
    • 1-2 years of project management experience.
    • Strong understanding of ICH guidelines and GCP principles.
    • Proficient in MS Office, MS Project, and PowerPoint.
    • Solid grasp of medical terminology and clinical trial processes.
    • Strong analytical skills and attention to detail.
    • Proficiency in written and spoken English.

About the Department

The Centralised Monitoring Unit (CMU) in Bangalore is part of Novo Nordisk’s Clinical Drug Development area, bringing together skilled medical professionals and technical programmers. The unit works on risk-based medical monitoring, ensuring patient safety, protocol adherence, and identifying potential clinical outliers. The team works closely with medical specialists and other departments to ensure effective centralized monitoring and the integrity of clinical trials.


About Novo Nordisk

Novo Nordisk is a global healthcare leader with over 100 years of experience in transforming the treatment of chronic diseases. With a focus on diabetes care, the company is expanding its reach to other therapeutic areas, impacting millions of patients globally. Novo Nordisk thrives on collaboration and the diverse perspectives of its employees, making a collective impact on global health.


How to Apply

Interested candidates are invited to submit their application, including CV, through Novo Nordisk’s online application tool.
Deadline: 7th February 2025.