Safety Surveillance Adviser I (Bengaluru)

Safety Surveillance Adviser I (Bengaluru)

10 Aug
|
Novo Nordisk
|
Bengaluru

10 Aug

Novo Nordisk

Bengaluru

Company: Novo Nordisk Global Business Services (GBS)

Shape the safety profile of medicines that reach millions of patients worldwide – from first-in-human trials through to marketed products across diabetes, obesity, and rare diseases.

Your current role

As a Safety Surveillance Adviser in Global Patient Safety (GPS), you will be at the centre of product safety – establishing safety profiles during development, maintaining labelling for marketed products, and conducting ongoing surveillance of Novo Nordisk products across their entire lifecycle.

Your Key Responsibilities Will Include

Acting as Owner of the safety sections of labelling for the evolving Company Core Data Sheet (CCDS) for development products, maintaining labelling for marketed products, and providing safety input as a labelling change request (LCR) reviewer
Preparing relevant sections of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities




Establishing, operating, and chairing the Novo Nordisk cross-functional safety committee throughout the product lifecycle – presenting analysis and results of ongoing safety surveillance at pre-defined intervals for endorsements and recommendations
Providing safety input to Product Development Plans, Trial Outlines, Protocols, Clinical Trial Reports, Investigator's Brochures, integrated safety summaries, abstracts, and planned publications
Responding to enquiries from Health Authorities and Ethics Committees regarding safety aspects of protocols and Patient Information/Informed Consent, and ensuring deliverables to and from Data Monitoring Committees
Delivering proactive safety communication through participation in project and trial teams, and conducting Investigator training as required

Your new department

In Research & Development, you'll be part of a unit that explores bold scientific ideas and a

📌 Safety Surveillance Adviser I (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru

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