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Safety Surveillance Principal Specialist

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Novo Nordisk A/S

Gladsaxe, 1 stilling

- Pharmacovigilance
- Denmark - Bagsværd

Are you an MD with in-depth knowledge about treatment of obesity and obesity related conditions from a clinical setting? Is patient safety important to you? Do you want to play a key role in ensuring NN develops safe products for the management of obesity? You may then be our new colleague in Safety Surveillance.

About the department
Safety Surveillance (approximately 100 employees) is an area within Global Safety and is situated in Bagsværd. The employees are dedicated and skilled professionals and have the global responsibility for the surveillance of all safety information for all Novo Nordisk’s products right throughout the life cycle of the products.

The job
In relation to our marketed obesity product and obesity products in development you will be responsible for providing medical and clinical expertise, in relation to important safety issues, in communications to health authorities and various cross‑functional teams, such as safety committees, data monitoring committees, global project team/life cycle teams, and various external Key Opinion Leader meetings. You will deliver clinical, medical, and scientific expertise during all stages of the clinical development programme including the submission process of new drug applications.

You will ensure that you and people working with you in the therapeutic area are constantly kept updated with the newest relevant literature within the area and other products used for either obesity or co‑morbidities. You will collaborate closely with our stakeholders, especially colleagues from Medical and Science. Within the department you will also be responsible for review of aggregated safety reports, obtain high knowledge of our safety signal detection and benefit-risk evaluation processes.

You will work independently, but also in close collaboration with a team of highly skilled, committed and enthusiastic colleagues. Assuming responsibility, communicating information and taking action will be a part of your working day.

We are looking for a MD with a proven scientific background (doctoral thesis, PhD, or publications) and who have a special focus and interest within obesity, preferably with documented experience with diagnosis and treatment of obesity and obesity related conditions in a clinical setting.

You should have good knowledge and understanding of clinical pharmacology and clinical scientific methodologies. You are curious and have an analytical approach to your work and are able to present data in a clear way. Experience with drug development and/or pharmacovigilance and reporting of safety data from clinical trials is an added advantage.

As a person you are proactive, responsible, well‑organised, and able to work under pressure when needed. You are a team player and excellent at establishing contacts and collaborating with stakeholders, and enjoy sharing your knowledge with other team members.

You must be fluent in English, both written and spoken, and be an experienced user of MS Office (Excel, PowerPoint, Word, and Outlook).

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.

For further information please contact Hanne Gjeding Miles at +45 3079 2545 or David Truloff at +45 3079 0499.

22 November 2015.