Safety Surveillance Adviser I

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 new 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 Investigators 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 youll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity AI tools and human data to develop transformative therapies. Through collaboration and operational excellence we shape and deliver an innovative pipeline to meet future patient needs.

The Safety Surveillance Adviser team at Global Patient Safety (GPS) is based in Bangalore India and collaborates closely with global hubs in Søborg Denmark and other partner teams. The team is responsible for monitoring evaluating and communicating the safety profile of Novo Nordisk products across their lifecycle covering therapeutic portfolios in Diabetes Obesity and Rare Diseases. The atmosphere is dynamic collaborative and fast-paced with a shared mission to ensure patient safety and maintain a favourable benefit-risk balance.

Your skills & qualifications

Were looking for a Safety Surveillance Adviser who thrives in a fast-paced environment and is passionate about patient safety. Youll bring with you:

• A Masters degree in Medicine/MD post MBBS (preferred)
• Relevant experience in Signal Management Aggregate Management and Individual Case Safety Report (ICSR) handling
• Ability and willingness to quickly adjust to changes in a continuously developing environment
• Comfortable use of the Microsoft Office package (Outlook Word Excel and PowerPoint)
• Strong communication skills and fluency in English with the ability to convey complex safety information clearly to diverse stakeholders

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with determination constant curiosity and a commitment to finding better ways forward. For over 100 years this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking shared purpose and mutual respect come together to create extraordinary results. When you join us youre not just starting a job youre becoming part of a story that spans generations.

What we offer

There is of course more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us while our benefits are designed with your career and life stage in mind.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.