Job Title: Safety Surveillance Adviser
Department: Global Safety - Global Business Services (GS-GBS)
Company: Novo Nordisk
Location: [Not Specified]
Application Deadline: 20th April 2025
Job Summary:
Join Novo Nordisk's dynamic Global Safety - Global Business Services (GS-GBS) department as a Safety Surveillance Adviser, contributing to global pharmacovigilance efforts. This role involves proactive drug safety surveillance, labelling oversight, and communication of safety data across clinical development and marketed products.
Key Responsibilities:
Maintain and establish product safety profiles during development and post-marketing.
Own the safety sections of labelling (CCDS) for development products.
Participate in Labelling Change Requests (LCR) reviews and provide safety input.
Author critical safety documentation: DSURs, SUSARs, PSURs, and RMPs.
Respond to safety-related queries from Health Authorities (HAs) and internal stakeholders.
Provide safety input to PDPs, trial protocols, CT reports, IBs, and publications.
Proactively engage in trial/project teams and investigator training.
Liaise with DMCs, HAs, and ECs regarding safety issues and deliverables.
Qualifications:
Education: Master's in Medicine / MD post-MBBS preferred.
Experience: Hands-on experience in:
Signal Management
Aggregate Report Management
ICSR Processing
Skills:
Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint)
Fluent in written and spoken English
Strong analytical, organizational, and communication skills
High quality and compliance mindset
Adaptive, proactive, and team-oriented
Cross-cultural awareness
About the Department (GS-GBS):
Established in 2010, GS-GBS specializes in end-to-end case processing from various sources including spontaneous reports, literature, and clinical trials. The department also manages medical reviews, safety submissions, IT QA, Argus system configuration, and other signal detection and training coordination functions.
About Novo Nordisk:
Novo Nordisk is a global leader in healthcare, impacting over 40 million lives worldwide. With 63,000+ employees and a legacy of innovation, the company champions diversity, collaboration, and a commitment to defeating chronic diseases.
Application Instructions:
Submit your CV and motivational letter via the official application portal.
Internal candidates: Inform your line manager before applying.
Important Notice:
Novo Nordisk does not request personal funds or paid training as part of the recruitment process. Beware of fraudulent job offers.
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