Safety Surveillance Process Specialist

Found in: beBee S DK - 1 month ago

Søborg, Denmark Novo Nordisk AS - VTx Full time

The position Safety Surveillance processes is a field of expertise that requires highly specialized knowledge of strategic importance to the SVP area. The ideal candidate will have proven subject matter expertise within Signal detection and risk management and experience with process management and compliance. As a Safety Surveillance Process Specialist, you will be recognized as an expert within one or more key processes across Safety Surveillance. You will be involved in various tasks across Safety Surveillance including audits and inspections, monitoring of compliance and deviations in close cooperation with relevant colleagues, and process improvement projects focused on the changes to processes. The key tasks include: Key responsible for the Safety Surveillance contribution to audits and inspections in Global Safety, other HQ functions, and affiliates Chairs Safety Surveillance compliance forum, with focus on decision making and oversight of changes to the Safety Surveillance processes and monitoring of compliance and deviations Drives Regulatory Surveillance of guidelines affecting Safety Surveillance to ensure full compliance with applicable legislation Manages process-related changes and deviations in Safety Surveillance in close cooperation with relevant colleagues Acts as Process Expert or back-up for Safety Surveillance processes You will get the opportunity both to work independently and in collaboration with a team of highly skilled, committed, and enthusiastic colleagues. You will establish close partnership and interaction with other functional areas within Global Safety and across Novo Nordisk. Assuming responsibility, communicating information and taking action will be essential parts of your workday. Qualifications To be a competitive candidate, you should have: A PhD or Master’s degree in natural science At least, 5-7 years of experience within drug safety/pharmacovigilance, within Signal Detection and Risk Management processes Experience working within audits and inspections A solid understanding of medical concepts, disease processes, scientific methodology and data analysis Experience with clinical development projects and/or documented scientific training (e.g., PhD) will be an advantage. As a person, you are ethical, responsible, well-organized and a strong communicator. You can work under pressure when needed. You are a strong collaborator and a dedicated team player who thrives in a multicultural environment of continuous development, and you are good at establishing contact and collaborating with stakeholders. You are fluent in English both written and spoken (company language) and an experienced user of MS Office. About the department Safety Surveillance is a department within Global Safety and is situated in Søborg, Denmark. We also have departments in Bengaluru (Bangalore), India and Boston, US. We are globally accountable for surveillance of all safety information for Novo Nordisk’s products that are currently marketed or under development. We additionally manage safety label updates, preparation of Risk Management Plans and aggregate reports. Working at Novo Nordisk At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.

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