Senior Medical Reviewer

Novo Nordisk

3-5 years

Not Disclosed

Bangalore India

10 Feb. 12, 2025

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)
Job Category: Clinical Development
Application Deadline: 21st February 2025

ABOUT THE DEPARTMENT

The Centralised Monitoring Unit (CMU) in Bangalore is a key department within the Clinical Drug Development area at Novo Nordisk. The team combines skilled medical professionals (Medical Reviewers) with technical experts (Functional Programmers, Statistical Monitors). The primary focus of the department is Risk-based medical monitoring, ensuring patient safety, protocol adherence, and identifying significant outliers in clinical data for timely intervention. The team uses advanced data visualization tools and statistical monitoring to support proactive centralized monitoring across clinical trials.

POSITION SUMMARY

The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data in various therapeutic areas within the drug development portfolio. This role plays a crucial part in ensuring the quality and consistency of medical data, emphasizing patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, and relevant regulations.

KEY RESPONSIBILITIES

Medical Review: Conduct comprehensive medical reviews of clinical trial data across various therapy areas.
Collaboration: Work closely with study team members, including Data Managers, Trial Managers, and Medical Specialists, to ensure protocol compliance and data integrity.
Quality Checks: Contribute to trial planning and perform quality checks for medical review measures.
Issue Resolution: Identify and resolve medical concerns or inconsistencies in clinical trial data, working with investigational sites.
Presentation of Findings: Present findings of medical reviews to Medical Specialists for informed decision-making.
Documentation: Document medical reviews in the Sponsor TMF and ensure thorough record-keeping.
Training: Provide training on the project and processes to new team members.
Data Inputs: Review and provide inputs for Medical Monitoring Plans (MMP), data displays, and data listings to ensure clear monitoring requirements.
Monitoring & Reporting: Monitor clinical data for unusual patterns, inconsistencies, or deviations from the protocol and escalate when necessary.
Collaboration on Trial Conduct: Engage in close collaboration with team members, particularly Data Managers and Trial Managers, throughout the trial process.
Continuous Improvement: Work towards enhancing the overall medical review process and ensuring efficient operations.

QUALIFICATIONS

Education:
- Graduate degree in Medicine or a related field is required (MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience in clinical research or patient management will also be considered).
Experience:
- 3-5 years of relevant experience in Clinical Drug Development, specifically in Medical Data Review, Medical Monitoring, Safety Surveillance, and related areas.
- 1-2 years of project management experience is essential.
Knowledge:
- Solid understanding of ICH guidelines and Good Clinical Practice (GCP) principles.
- Strong grasp of medical terminology and clinical trial processes.
Technical Skills:
- Proficiency in Microsoft Office (MS Word, Excel, PowerPoint), MS Project, and other relevant software tools.
Language Skills:
- Exceptional proficiency in written and spoken English.
Analytical Skills:
- Strong analytical and problem-solving abilities with a results-oriented approach.

WORKING AT NOVO NORDISK

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Our success is driven by more than 63,000 employees worldwide who collaborate to make a difference in the lives of millions of patients. As part of a team committed to improving patient lives, you will have the opportunity to contribute to one of the most valuable companies globally.

HOW TO APPLY

Submit your CV online via the Apply button by 21st February 2025.

Important Notice:
Please be aware of fraudulent job offers claiming to be from Novo Nordisk. Novo Nordisk does not extend unsolicited job offers or request personal information, funds, or equipment purchases as part of the recruitment process. Always verify the authenticity of the job offers through official channels.

Novo Nordisk is committed to creating a diverse and inclusive workplace, celebrating the unique perspectives, backgrounds, and cultures of our employees, patients, and communities. Together, we’re life changing.

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