Senior Medical Reviewer

Novo Nordisk

5 - 10 years

5 - 9 Lacs

bengaluru

Posted:-1 days ago| Platform:

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Skills Required

medical quality control mbbs data cleaning gcp stakeholder management compliance data systems clinical trials pharmacovigilance healthcare

Work Mode

Work from Office

Job Type

Full Time

Job Description

As a Senior Medical Reviewer, you will play a critical role in ensuring the quality and consistency of medical data across clinical trials. Your key responsibilities will include:

Conducting medical reviews of clinical trial data to ensure patient safety, protocol compliance, and adherence to regulatory requirements. Collaborating closely with study group members, including Data Managers, Trial Managers, and Medical Specialists, to ensure high-quality deliverables.
Identifying and resolving issues of medical concern and inconsistencies in clinical trial data with investigational site staff and healthcare professionals. Presenting findings of medical reviews to relevant Medical Specialists to enable informed decision-making.
Documenting medical reviews in the sponsor Trial Master File (TMF) and always ensuring inspection readiness. Performing quality control of medical review tasks and findings.
Providing training and mentoring to new team members, including therapeutic area training and process guidance. Contributing to shared best practices, process improvements, and other activities to ensure the team meets timelines and quality standards.
Planning and managing resources for medical review tasks, including timeline planning and resource allocation.

Qualifications

We are looking for a highly skilled and motivated individual who meets the following criteria:

A graduate degree in MBBS+MD with 5+ years of experience
Good knowledge of ICH GCP guidelines.
Demonstrated computer skills (MS Office, MS Project, PowerPoint).
Excellent understanding of medical terminology and clinical trial activities, Experience with risk-based monitoring methodologies. - Familiarity with clinical trial data systems and tools.
Excellent written and spoken English, Strong analytical and result-oriented skills, Ability to plan and handle complex tasks independently, good communication and stakeholder management skills

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