Are you motivated by challenges and thrive in a dynamic work environment? Do you excel in roles that require close collaboration with key stakeholders and strategic alignment? If you have a can-do attitude and a passion for continuous improvement, Novo Nordisk invites you to apply for the Safety Surveillance Adviser I position in Bangalore.
About Novo Nordisk
Novo Nordisk is a global healthcare leader with more than 95 years of innovation in diabetes care. Headquartered in Denmark, the company operates in over 80 countries, driving change to defeat serious chronic diseases. With a strong focus on patient safety and regulatory compliance, Novo Nordisk is committed to improving lives through cutting-edge medical solutions.
Job Description
As a Safety Surveillance Adviser, you will play a critical role in:
- Establishing the safety profile of products during development and maintaining labeling for marketed products.
- Conducting ongoing safety surveillance of Novo Nordisk (NN) products in pre-approval and post-approval phases, analyzing global safety data.
- Communicating drug safety concerns internally and to health authorities (HAs) as required.
- Chairing cross-functional safety committees, presenting safety data for risk assessment and decision-making.
- Managing patient safety in clinical trials, ensuring compliance with regulatory standards.
Key Responsibilities:
✔ Labeling & Safety Documentation:
- Own safety sections of the Company Core Data Sheet (CCDS) for developmental products.
- Review Labeling Change Requests (LCRs) and provide safety inputs.
✔ Regulatory & Compliance Reporting:
- Author Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
- Respond to health authority (HA) inquiries and internal safety-related requests.
✔ Clinical Trial Safety Oversight:
- Provide safety inputs to Product Development Plans (PDP), trial protocols, Investigator’s Brochures (IBs), and clinical study reports.
- Address Ethics Committees (ECs) and Data Monitoring Committees (DMCs) regarding safety concerns.
✔ Proactive Safety Communication:
- Train investigators on safety protocols.
- Participate in project/trial teams to ensure safety compliance.
Qualifications & Skills Required
✅ Education:
- MD (Post-MBBS) or Master’s in Medicine (preferred).
- Experience in Signal Management, Aggregate Reporting, and ICSR (Individual Case Safety Reports).
✅ Technical Skills:
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Strong analytical and problem-solving abilities.
✅ Soft Skills:
- Excellent communication (written & verbal).
- Proactive, detail-oriented, and quality-driven mindset.
- Ability to work in a cross-cultural, fast-paced environment.
Why Join Novo Nordisk?
- Global Impact: Work on life-changing therapies for chronic diseases.
- Career Growth: Opportunities for continuous learning and professional development.
- Innovative Culture: Be part of a collaborative, forward-thinking team.
