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Novo Nordisk

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4.1

based on 957 Reviews

Video summary

Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards

Top Rated Pharma Company - 2024

111 Novo Nordisk Jobs

Senior Medical Reviewer

Novo Nordisk India

4.1

based on 957 Reviews

2-3 years

Bangalore / Bengaluru

1 vacancy

Senior Medical Reviewer

Novo Nordisk

posted 10mon ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacovigilance Healthcare Clinical Research Project Management MS Office GCP

+ 3 more

Job Description

The Key Responsibilities in this position will be to perform a Medical Review of all trial subjects of all assigned clinical trials within the drug development portfolio across therapy areas & to ensure high-quality quality consistent medical data
Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and Standard Operating Procedures (SOPs)
Senior Medical Reviewer ensures high-quality medical data through medical review of clinical trial data
Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialists during trial conduct
Report the status of the medical review to the project as appropriate, following the project communication plan and blinding plan
Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manne
Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review.
Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites.
Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF.
Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members.
Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review.

Qualifications:

Minimum as Graduate in Medicine or other relevant (MBBS & MD in pharmacology preferred, MBBS & MD in other clinical/paraclinical areas with relevant experience in clinical patient management/ clinical research).

2-3 years of experience as a Medical Reviewer is preferred.

1-2 years of experience in project management is required.

Good knowledge of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), and GCP (Good Clinical Practice).