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Safety Surveillance Specialist

Category:  Clinical Development and Medical
Location: 

Bagsværd, Capital Region of Denmark, DK

   

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 oral semaglutide team.

 

About the department

Safety Surveillance is a department within Global Safety and is situated in Bagsværd, Denmark. Our team of dedicated and skilled professionals has global responsibility for 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 supporting the ongoing safety surveillance of one or more key semaglutide products for diabetes treatment in clinical development/early post-marketing stage.

 

It will be your job to

  • Perform critical analysis and medical evaluation of the emerging safety data from clinical trials, marketed use, published literature and regulatory databases
  • Be responsible for understanding the product safety profile and developing and maintaining the reference safety information (RSI) and the labelling for Novo Nordisk products
  • Participate in preparation of communication about the product specific data and the benefit risk assessment across a number of documents (e.g. PSUR, DSUR, RMP)
  • Actively contribute to 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
  • Represent Safety Surveillance in cross-functional teams
  • Potentially chair a cross-functional drug safety committee and be responsible for communication with external parties related to clinical safety monitoring such as Data Monitoring Committees
  • Establish close collaboration and interaction with other functional areas in Novo Nordisk especially Development, Regulatory Affairs and other Global Safety functions as applicable

 

You will bring broad and in-depth understanding of medical concepts, disease processes, data analysis and data evaluation. You will get the opportunity to work independently as well as within a team of highly skilled, committed, and enthusiastic colleagues. Assuming responsibility, communicating clearly and taking action will be essential parts of your workday.

 

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 years of 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 a strong driver and you thrive in in a fast-paced environment in continuous development and can make independent decisions regarding drug safety issues. You are good at establishing contact and collaborating with stakeholders. Further you are 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, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we are all working to move the needle on patient care.

 

Contact

For further information, please contact Ida Carøe Helmark at +45 3075 3696.

 

Deadline

Please apply for the position no later than 27 June 2021.

 

Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

 

Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.