Safety Surveillance Lead — Health Authority Expert

Novo Nordisk; Gladsaxe Kommune; On-site; DKK 847,000 - 1,245,000; Full time

Job summary

Novo Nordisk in Søborg, Denmark, seeks a Safety Surveillance Principal Specialist to lead the safety surveillance strategy for responses to Health Authority questions across the incretin portfolio, mainly within diabetes and obesity treatment. You will drive benefit–risk thinking, influence critical decisions and represent Safety Surveillance in Health Authority meetings.

The role spans safety input to studies and regulatory submissions, with cross‑functional collaboration across Clinical

Qualifications

• Master's degree in Life Sciences or related field.
• Extensive experience in drug safety and pharmacovigilance.
• Experience with global regulatory requirements and GxP.
• Ability to identify challenges and shape strategies.
• Strong stakeholder management and influencing skills.
• Experience with Health Authority negotiations and meetings.
• Clear written and verbal communication; ability to simplify complexity.
• Self-driven, ethical, adaptable and collaborative.

Responsibilities

• Lead safety surveillance for strategic, scientific responses to Health Authority Q&A across incretin portfolio.
• Maintain oversight of studies, submissions and Health Authority interactions.
• Represent Safety Surveillance in Health Authority meetings.
• Ensure input to study reports, regulatory submissions, protocols and related documents.

Skills

Drug safety

Pharmacovigilance

Regulatory requirements

GxP standards

Stakeholder management

Health Authority negotiations

Communication

Independent working

Team collaboration

Education

Master's degree in Life Sciences

Job description

Novo Nordisk in Søborg, Denmark, seeks a Safety Surveillance Principal Specialist to lead the safety surveillance strategy for responses to Health Authority questions across the incretin portfolio, mainly within diabetes and obesity treatment. You will drive benefit–risk thinking, influence critical decisions and represent Safety Surveillance in Health Authority meetings.

The role spans safety input to studies and regulatory submissions, with cross‑functional collaboration across Clinical