Senior Safety Surveillance Adviser for Semaglutide s.c. Global Safety
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Søborg
- Clinical Development & Medical
- Søborg
Would you like to be a driving force in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk diabetes products? And would you like to be part of one of the most skilled and advanced safety functions in Denmark? Then you may be our new colleague in the semaglutide se team.
About the department
Safety Surveillance is a department within Global Safety and is situated in Bagsværd, Denmark. Global Safety is an organisation of more than 400 highly professional people with a high level of educational background within natural science. Safety Surveillance has the global responsibility for the surveillance of all safety information for Novo Nordisk’s products that are currently marketed or under development worldwide.
The position
You will together with colleagues be responsible for signal detection and management which includes the critical analysis and medical evaluation of the emerging safety data from clinical trials, marketed use, published literature and regulatory databases. You will be responsible for understanding the product safety profile and developing and maintaining the reference safety information (RSI) and the labelling for Novo Nordisk products. You will also be responsible for communication about the benefit risk assessment (Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR) and Risk Management Plan(RMP)) and you will be our safety representative in cross-functional teams.
Furthermore, you will play an important role in the development of clinical trial protocols and clinical trial reports where you with your expertise will provide medical/clinical input on collection and assessment of safety information. Your job responsibilities may also include chairing a cross-functional safety committee and communication with external parties related to clinical safety monitoring such as Data Monitoring Committees.
You will bring broad and in-depth understanding of medical concepts, disease processes, data analysis and data evaluation. You will get the opportunity both to work independently as well as within a team of highly skilled, committed and enthusiastic colleagues. Assuming responsibility, clear communication and taking action will be essential parts of your work day. You will have a close collaboration and interaction with other functional areas in Novo Nordisk especially Global development, Regulatory Affairs and other Global Safety functions as applicable.
Qualifications
You hold a university degree in Medicine, Veterinary Medicine, Pharmacy or Biological Sciences preferably supplemented with scientific training, e.g. PhD. Additionally, you have solid experience within pharmacovigilance or extensive experience from clinical development and strong urge to specialise within pharmacovigilance.
As a person you have high ethical standards, you are responsible, well-organised and a strong communicator. You are able to work under pressure when needed and able to make independent decisions regarding drug safety issues.
You thrive in in a fast-paced environment in continuous development and you are good at establishing contact, collaborating and communicating with stakeholders. You are a strong driver and a dedicated team player and enjoy supporting and challenging your colleagues.
You are fluent in English both written and spoken (company language) and an experienced user of MS Office.
Working at Novo Nordisk
At Novo Nordisk your skills, commitment and ambition help us change lives for diabetes patients for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.
Contact
For further information, please contact Ida Carøe Helmark at +45 3075 3696.
Deadline
18 August 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 "Data Manager", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 12.7.2019, 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.
- Data Manager
- Søborg
- Søndag den 18. august 2019
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