Senior Clinical Safety Associate
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Bagsværd
- Clinical Development & Medical
- Bagsværd
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 Senior Clinical Safety Associate we are looking for.
About the department
The Case Management team is part of Safety Operations and is 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 the 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
As a Senior Clinical Safety Associate 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 skills to evaluate and process individual case stories and it is expected that you can provide guidance to colleagues and relevant stakeholders in all case handling aspects.
As a Senior Clinical Safety Associate you should 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 in other parts of the organisation. Additionally, you will be responsible for preparing 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. Deadlines, cross-functional collaboration, and international communication will be part of your workday.
Qualifications
You have an educational background as a registered nurse or other health care related background at bachelor’s degree level and minimum 3 years of experience within the pharmacovigilance and case handling field. You have in depth knowledge of all clinical case handling processes and are able to explain case handling processes with reference to relevant Standard Operating Procedure (SOPs), working instructions and regulatory requirements.
You are proficient within both written and spoken English. You have flair for using IT systems and you are highly skilled within 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.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information, please contact Mette Brinckmeyer at +45 3075 7465 or Lotte Finderup at +45 3079 5078.
Deadline
25-Aug-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.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 17.8.2019, 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.
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