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stillingsbetegnelse: Senior Safety Surveillance Adviser

jobbeskrivelse:

Do you like to be a driving force in ensuring highest safety and lowest possible risk to patients that use liraglutide? And would you like to be part of one of the most skilled and advanced safety functions in Denmark? If you find this challenging you may be our new colleague.

About the department
Safety Surveillance is a department within Global Safety and is situated in Bagsværd, Denmark. Our group of dedicated and skilled professionals has global responsibility for the surveillance of all safety information for Novo Nordisk’s products that are currently under development.

The position
You will be primarily 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 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 or 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 Clinical Development, Regulatory Affairs and other Global Safety functions as applicable.

Qualifications
You hold a university degree in Medicine, Veterinary Medicine, Pharmacy or Biological Sciences preferable supplemented with scientific training, e.g. PhD. Additionally, you must have solid experience within pharmacovigilance or extensive experience from clinical development and strong urge to specialise within pharmacovigilance. Furthermore, you have the ability to evaluate impact and consequences of disease conditions and medical interventions.
 
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 a multicultural environment of 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, 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 Kishore Saha at +45 3079 8430.

Deadline 
10. October 2018

 

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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2423

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: NOVO NORDISK A/S

source: DK-STAR