Safety Surveillance Advisor
1 month ago
About the Role
We are seeking a highly skilled Safety Surveillance Adviser to join our Global Safety team at Novo Nordisk A/S. As a key member of our team, you will be responsible for ensuring the safety of our products throughout their lifecycle.
Key Responsibilities
- Establish and maintain the product safety profile during development and maintenance of labelling for marketed products.
- Perform ongoing and systematic surveillance of Novo Nordisk products during pre-approval and post-approval phases.
- Communicate drug safety issues internally and to health authorities as required.
- Establish, operate, and chair the Novo Nordisk cross-functional safety committee throughout the lifecycle of the product.
- Prepare relevant sections of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs).
- Provide safety input to Product Development Plans (PDP), Trial Outlines, Protocols, Clinical Trial Reports, and Investigator's Brochures.
- Provide proactive safety communication and conduct Investigator training as required.
Requirements
- Masters in Medicine or MD post MBBS graduate is preferred.
- Relevant experience in signal management, aggregate management, and ICSR.
- Comfortable user of Microsoft Office package (Outlook, Word, Excel, and PowerPoint).
- Fluent in written and spoken English.
- Analytical mind-set, professional authority, and quality mind-set.
- Strong communicator, team player, and cross-cultural awareness.
About the Department
Global Safety - Global Business Services (GS-GBS) is a hub for safety case processing, handling case processing from different sources, including spontaneous, literature, solicited, and clinical trials. We are responsible for complete case processing and medical review, safety report submission, training, Learn It administration, quality control of Individual Case Safety Reports (ICSR), Argus configuration and maintenance, information technology quality assurance, signal detection activities, risk mitigation activities, training coordination, and literature surveillance activities.
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