Do you want to contribute to the safety and quality of Novo Nordisk clinical development? Do you have the experience within pharmacovigilance it takes to handle and supervise on handling adverse events reported from clinical trials? Would you enjoy being a key player in making sure that global regulatory requirements are met? Then you might be the Clinical Safety Professional we are looking for in a temporary position with end 31st December 2024.
About the department
Safety Operations Case Management Department is a part of Safety Operations and one of the functional 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
As a Clinical Safety professional, you will be responsible for handling adverse events reported world-wide from Novo Nordisk clinical trials to ensure that global regulatory requirements are met. You should use your medical background to evaluate and process individual case safety reports and it is expected that you can provide guidance to colleagues and relevant stakeholders in all case handling aspects.
You should also be able to foresee which impact, changes to case handling related processes will have on other interlinked and related processes. The job may involve participation in projects in Global Safety, or involvement in updates of standard operating procedures (SOPs)/working instructions where it is expected that you can act independently as Subject Matter Expert within the case handling field.
Furthermore, you will also have responsibilities related to dedicated clinical trials, where you will be main contact from case handling team to relevant stakeholders on larger clinical trials regarding specific safety issues. Deadlines, cross-functional collaboration, and international communication will be part of your workday. In addition, you will be involved in the trial initiation phase for all types of clinical trials, where you will ensure trial set-up that supports case handling activities and you will act as mentor for colleagues on these trials. Moreover, you will be part of our case management trial initiation group/forum.
Qualifications
You have an educational background with a B.Sc. degree or M.Sc. degree, registered nurse or equivalent within health science and documented +4 years-experience within pharmacovigilance and case handling. Preferable you have experience from a wide range of case handling related activities e.g. training responsibilities, subject matter expert experience or pharmacovigilance audit/inspection experience. Most importantly you have extensive knowledge of pharmacovigilance principles as well as clinical trial regulations and regulatory requirements. In addition, you have experience with clinical trial and project management processes, and substantial experience with MS Office.
As a person you are self-driven, have excellent learning- and analytical skills with a strong ability to communicate, plan and coordinate multiple simultaneous activities. You work in a structured manner with a sense for details. You promote knowledge sharing and focus on ‘win-win’ solutions. You are diligent, show flexibility and are a good team player. Familiarity with Novo Nordisk products and GCP is an advantage.
We offer an exciting job with lots of challenges among good colleagues in a positive working environment. The application should be written in English.
Contact
For more information please contact Lotte Finderup Kystol at +45 3079 5078 or Sanne Lassen Aasted at +45 3075 0348.
Deadline 10-SEP-2023
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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