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Senior Medical Reviewer

1-2 years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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)

About Novo Nordisk:

Novo Nordisk is a global healthcare leader with a 100-year legacy of driving change in chronic disease treatment. We have a strong presence in diabetes care and are expanding our impact worldwide, reaching over 40 million patients daily. We are committed to building a diverse, collaborative workforce to drive life-changing innovations. Join us in making a difference.

The Position:

The Senior Medical Reviewer will play a crucial role within the Centralised Monitoring Unit (CMU), a dynamic team focused on risk-based medical monitoring in clinical trials. This role requires in-depth medical expertise to ensure patient safety, protocol compliance, and high-quality data review. The Senior Medical Reviewer will collaborate closely with cross-functional teams to identify inconsistencies in clinical data, resolve medical concerns, and maintain trial integrity.

Key Responsibilities:

  • Medical Review: Conduct comprehensive medical reviews of clinical trial data, ensuring adherence to protocols and compliance with Good Clinical Practice (GCP) and ICH guidelines.
  • Collaboration: Work with Data Managers, Trial Managers, and Medical Specialists to resolve medical concerns and clarify data inconsistencies.
  • Trial Support: Contribute to trial planning and provide quality checks for medical reviews. Provide timely updates on review progress and escalate issues when necessary.
  • Training & Guidance: Mentor new team members and provide training on medical review processes.
  • Data Review: Review and provide input on medical monitoring displays and data listings, ensuring clear medical requirements for monitoring.

Qualifications:

  • Education: Graduate degree in Medicine (MBBS & MD in Pharmacology preferred, but other clinical or paraclinical areas with relevant experience in clinical patient management or clinical research will also be considered).
  • Experience: 3-5 years in Clinical Drug Development (Medical Data Review, Medical Monitoring, Safety Surveillance).
  • Project Management: 1-2 years of project management experience.
  • Skills:
    • Strong understanding of ICH guidelines and GCP principles.
    • Proficiency in MS Office, MS Project, and PowerPoint.
    • Excellent grasp of medical terminology and clinical trial processes.
    • Strong analytical skills and results-driven approach.
    • Fluency in written and spoken English.

Working at Novo Nordisk:

Novo Nordisk is committed to creating a culture of collaboration, innovation, and diversity. With a workforce of over 63,000 employees worldwide, we work together to make life-changing differences in the lives of millions of patients. Join us and be part of a company that is shaping the future of healthcare.

Application Process:

To apply, please upload your CV online through the application portal.

Deadline: Please submit your application by December 20, 2024.

Novo Nordisk promotes an inclusive recruitment process and provides equal opportunity for all candidates.