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Senior Medical Reviewer

3-5 years
Not Disclosed
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 century-long legacy of driving change to defeat serious chronic diseases. With our strong foundation in diabetes, we are growing rapidly, reaching millions of people worldwide, and impacting the lives of more than 40 million patients daily. We are among the 20 most valuable companies globally by market capitalization.

Our success stems from the collaboration of over 63,000 employees worldwide. We value the unique skills and perspectives each individual brings to the table and work to bring out the best in all our employees. Join us, and together we will make a difference. Together, we’re life-changing.


Department Overview: Centralised Monitoring Unit (CMU)

The Centralised Monitoring Unit (CMU) in Bangalore is part of Novo Nordisk’s Clinical Drug Development division. The CMU is a cross-functional team composed of medical reviewers, technical programmers, and statistical monitors.

  • Medical reviewers are responsible for risk-based medical monitoring and ensuring patient safety during clinical trials. They collaborate with medical specialists and focus on compliance, protocol adherence, and identifying clinically significant outliers.
  • Functional programmers develop operational visualizations to support proactive monitoring.
  • Statistical monitors detect unusual data patterns, errors, and potential non-compliance across clinical trials.

The CMU plays a critical role in supporting the development of safe and effective treatments.


The Role: Senior Medical Reviewer

Location: Bangalore
Note: This is not a role within Pharmacovigilance.

The Senior Medical Reviewer is responsible for conducting thorough medical reviews of clinical trial data across various therapeutic areas within the drug development portfolio. This role ensures the quality and consistency of clinical trial data, focusing on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, and local regulations.

Key Responsibilities

  • Trial Planning and Execution: Contribute to trial planning activities related to medical review and perform quality checks on medical reviews.
  • Data Review: Review clinical trial data, identify medical inconsistencies, and resolve issues with staff at investigational sites.
  • Collaboration: Work closely with study team members (Data Managers, Trial Managers, and Medical Specialists) and escalate issues to maintain trial integrity and compliance.
  • Medical Review Reporting: Present medical findings to medical specialists and document medical reviews in the sponsor’s Trial Master File (TMF).
  • Training: Provide training to new team members on project processes and medical review.
  • Input to Medical Monitoring: Review and provide inputs to Medical Monitoring Plans (MMP), data listings, and medical monitoring displays to ensure effective and clear medical reviews.

Qualifications

  • Education: Graduate degree in Medicine or a related field (MBBS & MD in Pharmacology preferred; other MBBS & MDs with clinical research experience will also be considered).
  • Experience:
    • 3-5 years of relevant experience in Clinical Drug Development, including Medical Data Review, Medical Monitoring, Safety Surveillance, or Scientific Clinical Drug Development.
    • 1-2 years of project management experience is essential.
  • Knowledge: Solid understanding of ICH guidelines, GCP principles, and clinical trial processes.
  • Skills:
    • Proficiency in computer applications, including MS Office, MS Project, and PowerPoint.
    • Strong understanding of medical terminology.
    • Analytical mindset with a results-oriented approach.
    • Exceptional written and spoken English communication skills.

Working at Novo Nordisk

At Novo Nordisk, we are committed to creating an inclusive and diverse culture that celebrates the unique backgrounds, experiences, and perspectives of our employees. We believe in the power of collaboration and value the contributions of every individual in achieving our mission to create life-changing impact.


Application Process

To submit your application, please upload your CV online by following the application instructions.

Deadline: November 20th, 2024.


Important Disclaimer

We have been made aware of fraudulent job offers claiming to be from Novo Nordisk. Be cautious of any unsolicited job offers asking for personal information, fees, or the purchase of equipment. Novo Nordisk does not extend unsolicited employment offers or request funds as part of the recruitment process.


Equal Opportunity Commitment

At Novo Nordisk, we are committed to an inclusive recruitment process and provide equal opportunities for all applicants. We embrace diversity and work to create a culture that celebrates the unique qualities of our employees and the communities we serve. Together, we’re life-changing.


Contact

For inquiries or more details, please refer to the Novo Nordisk Careers Page.