Are you passionate about ensuring patient safety and working in a dynamic, international environment? Do you thrive on challenges and have a can-do attitude? Novo Nordisk, a global leader in healthcare, is looking for a Safety Surveillance Adviser I to join our Global Safety – Global Business Services (GS-GBS) team in Bangalore. If you are motivated by continuous improvement and collaboration with key stakeholders, this could be the perfect opportunity for you.
About Novo Nordisk
Novo Nordisk is a world-renowned healthcare company with a 100-year legacy of combating chronic diseases. As a leader in diabetes care, we are expanding our impact globally, improving the lives of over 40 million patients daily. With a workforce of more than 63,000 employees worldwide, we are committed to driving change and fostering innovation. Our success is built on collaboration, diversity, and the unique skills of our people.
Job Description
As a Safety Surveillance Adviser I, you will play a critical role in ensuring the safety of Novo Nordisk products throughout their lifecycle. Your responsibilities will include:
- Product Safety Profile Development:
- Establish and maintain the safety profile of products during development and post-approval phases.
- Conduct systematic surveillance of safety information from global sources.
- Labelling and Documentation:
- Own the safety sections of the Company Core Data Sheet (CCDS) for development products.
- Maintain labelling for marketed products and review Labelling Change Requests (LCRs).
- Safety Reporting:
- Prepare key sections of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
- Respond to inquiries from Health Authorities (HAs) and internal stakeholders.
- Cross-Functional Collaboration:
- Chair the Novo Nordisk cross-functional safety committee and present safety surveillance results.
- Provide safety input to Product Development Plans (PDPs), clinical trial protocols, and Investigator’s Brochures (IBs).
- Proactive Safety Communication:
- Participate in project and trial teams to ensure safety considerations are addressed.
- Conduct investigator training and respond to safety-related queries from Ethics Committees (ECs).
Qualifications
To excel in this role, you should have:
- A Master’s in Medicine (MD) post-MBBS (preferred).
- Relevant experience in Signal Management, Aggregate Reporting, and Individual Case Safety Reports (ICSRs).
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Fluency in written and spoken English.
- Strong analytical and communication skills.
- A quality-driven mindset with a focus on continuous improvement.
- Cross-cultural awareness and the ability to adapt to a fast-paced environment.
About the Department
The Global Safety – Global Business Services (GS-GBS) team, established in 2010, is a hub for safety case processing. We handle safety data from various sources, including clinical trials, literature, and spontaneous reports. Our team is also involved in signal detection, risk mitigation, training coordination, and medical literature monitoring.
Why Join Novo Nordisk?
- Be part of a global leader in healthcare with a legacy of innovation.
- Work in a collaborative and inclusive environment.
- Contribute to improving the lives of millions of patients worldwide.
- Enjoy opportunities for professional growth and development.
