Non Clinical Job at Novo Nordisk
A rare chance has emerged for aspiring professionals in the pharmaceutical sector as Novo Nordisk seeks a Safety Surveillance Adviser in Bangalore. This Novo Nordisk safety job offers the opportunity to shape the safety profile of medicines that impact millions globally, with a focus on diabetes, obesity, and rare diseases.
About Novo Nordisk:
Novo Nordisk is a global healthcare company specializing in diabetes care, obesity management, and treatment for rare diseases. With a commitment to innovation and patient safety, the organization operates worldwide, striving to provide effective therapies and improve the lives of patients. The company is headquartered in Denmark and has established a significant presence in Bangalore, India, where it drives research and development initiatives.
- Company: Novo Nordisk Global Business Services (GBS)
- Location: Bangalore, India
Safety Surveillance Adviser Role Description:
As a Safety Surveillance Adviser in Global Patient Safety (GPS), the successful candidate in this Novo Nordisk safety job will play a crucial role in establishing safety profiles during product development, maintaining labelling for marketed products, and conducting ongoing surveillance of Novo Nordisk products throughout their lifecycle.
Key Responsibilities:
- 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.
Safety Surveillance Adviser Role Eligibility Criteria:
- A Master’s 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.
This Novo Nordisk safety job represents a significant step for professionals passionate about patient safety and product development. Qualified candidates are encouraged to apply at the earliest to contribute to the mission of improving healthcare outcomes globally.
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