Senior Medical Reviewer

2+ years

Not Disclosed

Bangalore

10 Jan. 3, 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
Job Category: Clinical Development

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About the Position:

Are you motivated by challenges and working in dynamic environments? Do you thrive in roles that require close collaboration and strategic alignment with key stakeholders? If you are passionate about continuous improvement and patient safety, this could be the perfect opportunity for you. Join the Centralised Monitoring Unit (CMU) at Novo Nordisk in Bangalore, India, and play a pivotal role in clinical trial data review and medical monitoring.

As a Senior Medical Reviewer, you will be responsible for conducting comprehensive medical reviews of clinical trial data across various therapeutic areas. You will collaborate closely with cross-functional teams to ensure protocol adherence, compliance with Good Clinical Practice (GCP), and the highest quality of medical data.

Key Responsibilities:

Conduct medical reviews of clinical trial data with a focus on patient safety and protocol compliance.
Collaborate with Data Managers, Trial Managers, and Medical Specialists to address medical concerns and inconsistencies in clinical trial data.
Present findings of medical reviews to relevant Medical Specialists for decision-making.
Contribute to trial planning activities and provide training to new team members.
Review and provide input on medical monitoring displays, data listings, and other materials necessary for efficient medical review.
Escalate any issues to maintain trial integrity and compliance.

Qualifications:

A graduate degree in Medicine or a related field is required (MBBS & MD in Pharmacology preferred, but MBBS & MD in other clinical or paraclinical areas with relevant experience will also be considered).
3-5 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, etc.).
At least 1-2 years of project management experience.
Solid understanding of ICH guidelines and GCP principles.
Proficient in MS Office, MS Project, and PowerPoint.
Strong grasp of medical terminology and clinical trial processes.
Exceptional written and spoken English skills.

About the Department:

The Centralised Monitoring Unit (CMU) at Novo Nordisk in Bangalore is part of the Clinical Drug Development area. The CMU integrates skilled medical professionals and technical programmers, focusing on risk-based medical monitoring to ensure the safety and wellbeing of clinical trial participants. Medical reviewers, in close collaboration with medical specialists, ensure compliance and identify clinically significant outliers that need medical attention.

Working at Novo Nordisk:

Novo Nordisk is a global leader in healthcare with a 100-year legacy of driving change to combat serious chronic diseases. With a focus on innovation and improving patient lives, Novo Nordisk impacts over 40 million patient lives daily. Our success is driven by the collaboration of over 63,000 employees worldwide. Join us and be part of a team committed to life-changing work.

Application Deadline:

Submit your application by 10th January 2025. Please upload your CV online.

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Senior Medical Reviewer

Job Description

Apply Now

About the Position:

Key Responsibilities:

Qualifications:

About the Department:

Working at Novo Nordisk:

Application Deadline:

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