Job Title: Safety Surveillance Adviser
Department: Global Safety – Global Business Services (GS-GBS)
Company: Novo Nordisk
Location: Bengaluru, India
Application Deadline: 20th April 2025
Job Summary:
Novo Nordisk is looking for a Safety Surveillance Adviser to join the Global Safety – Global Business Services (GS-GBS) team. This role involves overseeing product safety profiles, maintaining labelling for marketed products, and ensuring proactive communication of drug safety issues during all phases of the product lifecycle.
Key Responsibilities:
Monitor and establish product safety profiles during development and post-marketing phases.
Maintain and update the Company Core Data Sheet (CCDS) and participate in labelling change reviews (LCR).
Author safety-related documents: DSURs, SUSARs, PSURs, Risk Management Plans (RMPs).
Respond to safety-related inquiries from Health Authorities (HAs) and internal stakeholders.
Provide safety input to Product Development Plans, protocols, trial reports, Investigator’s Brochures, and publications.
Participate in project and trial teams, conducting investigator training where required.
Liaise with Data Monitoring Committees (DMCs), respond to HA/Ethics Committee queries on safety matters, and ensure accurate deliverables.
Qualifications:
MD or Masters in Medicine (post MBBS) preferred.
Experience in Signal Management, Aggregate Management, and ICSR.
Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
Strong analytical, planning, and communication skills.
Proactive, detail-oriented, with a quality- and service-oriented mindset.
Able to adapt to a fast-changing environment and work cross-functionally.
About the Department:
Established in 2010, the Global Safety - GBS unit handles comprehensive safety case processing including literature, clinical trials, solicited/spontaneous sources. The team also oversees safety reporting, quality control, signal detection, risk mitigation, Argus system maintenance, and training support for global safety operations.
About Novo Nordisk:
Novo Nordisk is a leading global healthcare company with over 63,000 employees worldwide and a legacy of innovation spanning 100 years. The company is dedicated to improving lives by addressing chronic diseases and fostering an inclusive culture that values diversity, collaboration, and sustainable growth.
Application Instructions:
To apply, submit your CV and motivational letter through Novo Nordisk’s online application portal. Internal candidates should notify their line manager before applying.
Important Notice:
Beware of fraudulent job offers misrepresenting Novo Nordisk. The company does not request payments or equipment purchases as part of the recruitment process.
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