Senior Medical Reviewer

2-5 years

Not Disclosed

Bangalore

10 Jan. 7, 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 Description: Senior Medical Reviewer - Centralized Monitoring Unit (CMU)

Location: Bangalore, India
Job Category: Clinical Development

About the Department:

The Centralized Monitoring Unit (CMU) in Bangalore is a critical part of the Clinical Drug Development area, combining skilled medical professionals (Medical Reviewers) and technical experts (Functional Programmers, Statistical Monitors). The team works collaboratively to ensure patient safety, identify data outliers, and support clinical trial integrity. The CMU team provides essential services such as risk-based medical monitoring, operational data visualizations, and statistical analyses of clinical trial data to identify potential risks or compliance issues.

Position Overview:

The Senior Medical Reviewer plays a pivotal role in the medical review of clinical trial data across various therapeutic areas within our drug development portfolio. This position requires a focus on ensuring patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, and other applicable regulations. Key responsibilities include collaborating with trial team members, ensuring the accuracy and integrity of medical reviews, and escalating any critical issues that may affect trial progress.

Key Responsibilities:

Lead and contribute to planning activities related to medical reviews during clinical trials.
Perform quality checks to ensure the accuracy of medical reviews.
Resolve issues or inconsistencies in clinical trial data, collaborating with investigational site staff.
Present findings to relevant Medical Specialists for decision-making.
Document medical reviews in the Trial Master File (TMF).
Collaborate with Data Managers, Trial Managers, and Medical Specialists throughout the trial process.
Provide training to new team members and share expertise on project processes.
Review and offer insights into Medical Monitoring Plans (MMP), medical monitoring displays, and data listings.

Qualifications:

Education: Graduate degree in Medicine (MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience in clinical research will also be considered).
Experience: 3-5 years of experience in Clinical Drug Development (including Medical Data Review, Medical Monitoring, Safety Surveillance, etc.).
Project Management: 1-2 years of experience is essential.
Knowledge: Strong understanding of ICH guidelines, GCP principles, and medical terminology. Proficiency in MS Office, MS Project, and PowerPoint.
Communication: Exceptional proficiency in written and spoken English.

Working at Novo Nordisk:

Novo Nordisk is a global leader in healthcare with a 100-year legacy in addressing chronic diseases. As one of the top 20 most valuable companies globally, Novo Nordisk continues to grow and make a significant impact on the lives of millions of patients. Working with Novo Nordisk means contributing to life-changing work in an inclusive, collaborative, and diverse environment.

Application Deadline:

January 10, 2025

Application Process:

To apply, please upload your CV online by clicking on the 'Apply' button and following the instructions.

Important Notice:

Be cautious of fraudulent job offers claiming to be from Novo Nordisk. The company never extends unsolicited employment offers or asks for personal funds or payments during the recruitment process.

Commitment to Diversity and Inclusion:

Novo Nordisk is dedicated to fostering an inclusive culture and equal opportunity for all applicants. We celebrate the diversity of our employees, the patients we serve, and the communities we operate in.

Together, we’re life-changing. Join us!

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Senior Medical Reviewer

Job Description

About the Department:

Position Overview:

Key Responsibilities:

Qualifications:

Working at Novo Nordisk:

Application Deadline:

Application Process:

Important Notice:

Commitment to Diversity and Inclusion:

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