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Safety Surveillance Specialist
1 week ago
Category: Reg Affairs & Safety Pharmacovigilance
Location: Søborg, Capital Region of Denmark, DK
Do you want to lead and drive safety surveillance activities in development projects in rare diseases? And would you like to be part of one of the most skilled and advanced pharmacovigilance functions in Denmark?
Then, this might be a great opportunity for you to join Novo Nordisk We have open positions for experienced candidates in the Safety Surveillance Rare Disease team at Novo Nordisk.
About the department
Safety Surveillance Rare Disease is a team within Global Safety at Novo Nordisk. Our dedicated and skilled professionals have global responsibility for the establishment of the product safety profile during clinical development, and for performing critical analysis and medical evaluation of the emerging aggregate safety data.
In the Rare Disease team, we handle projects within the rare disease indication from development to post marketing. In collaboration with other colleagues in the team, you will be responsible for surveillance activities related to the compounds in development for rare blood and bleeding disease indications.
The position
Your responsibilities may include:
- Chairing cross-functional drug safety committees
- Preparing communication about the benefit risk assessment
- Contributing to development of clinical study designs and protocols
- Communicating with external parties related to clinical safety monitoring such as Data Monitoring Committees
- Representing Safety Surveillance in cross-functional teams
You will get the opportunity both to work independently and in collaboration with a team of highly skilled, committed, and enthusiastic colleagues across the functional areas in Novo Nordisk, especially the Non-clinical and Clinical Development teams. Assuming responsibility, communicating information and taking action will be essential parts of your workday.
We understand that candidates may have varying levels of experience, and we are open to adjusting the level of the role to some extent to match your unique skillset. However, it is important that candidates still possess the necessary experience within safety in drug development to thrive in this role.
Qualifications
You could be our ideal candidate if you have:
- Several years of experience within Safety Surveillance and development in the pharmaceutical industry
- A master's degree within Medicine or Natural Sciences e.g., Doctor of Medicine (MD), Doctor of Veterinary Medicine (DVM), Master of Science in Pharmacy or in human biology/physiology or equivalent, eventually complemented by a PhD/research experience
- Interest/experience in data analysis and analysis tools (e.g. JMP and/or Qlik Sense)
- Experience with rare diseases, hemophilia or hemoglobinopathies is an advantage
- The ability to work independently as well as to collaborate in a continuously developing environment
- Good skills in establishing contacts and collaborating with stakeholders in the organisation as well as externally
As a person, you are self-driven and able to work independently and under pressure when needed. You are ethical, responsible, well-organised and a strong communicator.
Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it. 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. From research and development, through to manufacturing, marketing and sales – we're all working to move the needle on patient care.
Contact
For further information, please contact Michala Gauguin, Safety Surveillance Rare Disease Manager at +45 30793866.
Deadline
12 January 2025
Kindly note that applications will be reviewed on an ongoing basis, so you are encouraged to apply as soon as possible.
We are looking for several safety profiles at Novo Nordisk. Therefore, hiring Managers from different teams might also look at your application. Please indicate in your application if we are not allowed to share your application.
Please include a few sentences about why you are applying for the position in your resume or CV. You do not need to attach a cover letter to your application. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.
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.
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