Associate Clinical Safety Professional
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Søborg
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. The position is a temporary position with end 31st December 2024. 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 14 highly engaged colleagues. The position 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 take part in the conduct of clinical trials. Here you will maintain overview of individual adverse event reports in a specific clinical trial and 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. Contact
For more information, please contact Sanne Lassen Aasted at +45 3075 0348 or Lotte Finderup Kystol at +45 3079 5078 . Deadline 22-Oct-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.
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 14 highly engaged colleagues. The position 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 take part in the conduct of clinical trials. Here you will maintain overview of individual adverse event reports in a specific clinical trial and 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. Contact
For more information, please contact Sanne Lassen Aasted at +45 3075 0348 or Lotte Finderup Kystol at +45 3079 5078 . Deadline 22-Oct-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.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 10.10.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Søborg
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