Safety Operations Specialist

vor 2 Wochen


Shire Of Denmark, Österreich Novo Nordisk AS Vollzeit

Safety Operations Specialist (parental leave cover - approx. 1 year) Category: Reg Affairs & Safety Pharmacovigilance Location: Søborg, Capital Region of Denmark, DK Do you want to use your expertise and quality mindset to make a tangible difference for patient safety in a professional, international environment? Do you thrive on translating regulatory and business requirements into practical, reliable processes for handling of individual safety cases? We are offering a temporary position covering parental leave as Safety Operations Specialist in Global Patient Safety. Your new role As Safety Operations Specialist, you will establish close partnership and interaction with other functional areas within Novo Nordisk. Your key responsibilities will be: You will be a driving factor between the key skill areas in Global Patient Safety and our stakeholders in other parts of Novo Nordisk dealing with impact assessments and anchoring of new regulatory requirements Good Pharmacovigilance Practice/ Good Clinical Practice (GVP/GCP), and the driver or key member of cross function activities or projects. You will be participating in GVP/GCP inspections and audits and subsequently be responsible for the handling of corrective and preventive actions. You will work both independently and collaboratively in a well‑functioning, engaged team. This is a high‑impact role: you will be expected to take ownership, set high standards and help raise patient‑safety practices across the global organisation. Your new department The Safety Operations Centre of Expertise & Submission team in Global Patient Safety is an international group with nine colleagues in Denmark and three in our hub in Bangalore. We are responsible for ensuring global regulatory compliance in the capture, processing and submission of patient safety information from clinical trials and the post‑marketing setting. We are engaged, highly skilled and down‑to‑earth people who work in a flexible, cross‑functional way. Collaboration and knowledge‑sharing are part of our everyday practice — we help each other to deliver high quality work that benefits patients. Right now the team is involved in an exciting transition to a new safety database, offering real opportunities to influence processes and systems. As a member of this diverse team you will be given real responsibility and receive the support you need to grow and develop professionally. Your skills and qualifications You hold a university degree in life sciences or another relevant field, but most importantly you bring: Strong knowledge of GVP and practical experience with GCP principles and international regulations. Demonstrated ability to translate regulatory requirements into Standard Operating Procedures. Experience participating in GVP/GCP audits and inspections. Knowledge of medical device regulation is an advantage. Comfortable learning and using new IT systems; experience with Veeva Safety is an advantage. As a person, you are self‑driven and motivated, taking ownership of your work and maintaining a clear overview of your own tasks and priorities. You are resourceful and pragmatic, able to balance attention to detail with keeping the bigger picture in mind. You thrive in a dynamic, collaborative environment with many stakeholders and communicate clearly, respectfully and effectively. Your drive and proactive approach help move initiatives forward and positively motivate colleagues. You act with openness, honesty, integrity and inclusiveness, serving as a constructive ambassador for the team and department. Fluency in spoken and written English is essential. Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years, this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results. What we offer There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. More information For further information, please contact senior manager Vibeke Gundstrup Meirum, phone Deadline 14th of December 2025 We encourage you to apply as soon as possible — applications will be reviewed on an ongoing basis. Please upload your CV only and include a short paragraph within the CV explaining why you are applying for this position. To ensure an efficient and fair recruitment process, please do not include a photo in your CV. Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long‑term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. #J-18808-Ljbffr



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