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Associate Clinical Safety Professional

  • Novo Nordisk
  • 2860Søborg,Danmark
  • 04/01/2023

Jobbeskrivelse

Do you want to contribute to the safety and quality of Novo Nordisk clinical development products? Would you like to use your medical knowledge to handle serious adverse events reported from clinical trials? Would you thrive in a well-regulated area where you make sure that global regulatory requirements are complied with? Then you might be the Associate Clinical Safety Professional we are looking for. About the department Safety Operations Case Management Department is part of Safety Operations and one of the operational areas in Global Safety. Global Safety is responsible for meeting global regulatory requirements for handling and reporting of adverse events and for the surveillance of safety and quality of Novo Nordisk clinical development and marketed products. We have three Case Management teams each consisting of 15 highly engaged colleagues. The position In order to ensure that global regulatory requirements are met, you will play a key role in handling serious adverse events reported from our clinical trials. You will make sure that the individual adverse event reports are accurately and consistently registered and evaluated in our database. Additionally, you will assess the reports including need of requesting missing information on the reported events. As Associate Clinical Safety Professional you will also have responsibilities related to clinical trials. Here you will be responsible for communication to relevant stakeholders regarding specific safety issues and other relevant information. Cross functional collaboration and internal communication will therefore be a part of your everyday work. Furthermore, you will assist with related administrative and procedural activities and ensure that all tasks are performed in compliance with GxP requirements. Qualifications You have an educational background with a B.Sc. degree or M.Sc. degree, registered nurse or equivalent within health science. Experience with clinical trials or pharmacovigilance and experience within the fields of diabetes, cardiology or obesity is an advantage. Most importantly you possess extensive knowledge of medicinal terminology and clinical pharmacology. In addition, you have an interest in and flair for using IT-systems and is highly skilled within MS Office. With regards to personal skills, you are known for your good analytical skills and ability to collaborate. You are detail-oriented, diligent and have strong communication skills. You enjoy working in a dynamic environment with changing short deadlines and you thrive in a role where you are required to plan and coordinate multiple simultaneous activities. Because you will be working with international stakeholders, it is a requirement that you are proficient in both written and spoken English.