Clinical Safety Associate for Global Safety (Maternity cover)

• Clinical Development & Medical
• Bagsværd

Do you want to contribute to the safety and quality of Novo Nordisk clinical development? Do you have the competence and the medical knowledge it takes to handle 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 Associate we are looking for.

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 two 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 defining 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 and assess the need of requesting missing or follow-up information on the reported events.

As Clinical Safety Associate you will also have responsibilities related to dedicated clinical trials. Here you will be in charge of the contact to relevant stakeholders regarding specific safety issues and you will ensure that the correct information is being communicated. 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 as a Registered Nurse or other health care related background at Bachelor’s degree level. Preferably you have previous involvement with Pharmacovigilance or experience as a study nurse. Experience within the field 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 being 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.

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact
For more information please contact Mette Brinckmeyer at +45 3075 7465 or Lotte Finderup at +45 3079 5078.

Deadline

12 Jul 2019.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.