Safety Surveillance Adviser I

Job description

**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 S borg, 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 Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.