Safety Surveillance Specialist, Biopharm Diabetes, Insulin & Devices, Global Safety
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Bagsværd
- Clinical Development & Medical
- Bagsværd
Do you like to be a driving force in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk (NN) products? And would you like to be part of one of the most skilled and advanced pharmacovigilance functions in Denmark? If you find this relevant and interesting, then you may be our new colleague in Safety Surveillance.
About the department
Safety Surveillance Biopharm Diabetes, Insulin & Devices 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 an educational background within life sciences.
Our team of dedicated and highly skilled pharmacovigilance experts has global responsibility for the signal detection and surveillance of all safety information for Novo Nordisk’s products that are currently marketed or under development in Biopharm, Diabetes Insulins and Devices portfolio.
The position
You will be supporting the ongoing safety surveillance of one or more key products in insulin portfolio and job responsibilities may include signal detection entailing critical analysis and medical evaluation of the emerging aggregate safety data from clinical trials, post-market use and published literature. Furthermore, providing safety input to aggregate safety data reports and risk management plans.
You will also be responsible for establishment and maintenance of the product safety profile during development and post-marketing as well as preparing communication about benefit-risk assessment to authorities & stakeholders. You will also be chairing and/or supporting a cross-functional drug safety committee and communication with external stakeholders related to clinical safety monitoring such as Data Monitoring Committees. In addition you will be responsible for providing input to clinical trial protocols and clinical trial reports on collection and assessment of relevant safety information, as applicable
You will be our safety representative in cross-functional teams and will have a close collaboration with other functional areas in Novo Nordisk especially the Non-clinical and Clinical Development, Medical Affairs and Regulatory Affairs teams.
You will get the opportunity both to work independently and in collaboration with a team of highly skilled, committed and enthusiastic colleagues. Assuming responsibility, communicating information and taking action will be essential parts of your work day.
Qualifications
You are a Medical Doctor or have university degree in life/natural sciences preferably supplemented with documented scientific training e.g. PhD.
In addition you must have
- Solid experience ( 5 years) within pharmacovigilance in pre & post-marketing setting or alternatively extensive experience within the pharmaceutical industry and strong urge to specialise within pharmacovigilance,
- Good understanding of medical concepts, disease processes, scientific methodology, drug development and documented scientific training,
- Good understanding of data analysis and problem solving skills,
- Excellent oral and written communication in English (company language),
- Proficiency in use of MS Office,
- Experience with working in multicultural teams (a plus).
As a person you must have high ethical standards, you are responsible, well-organised and a strong communicator with an ability to adapt and drive constant change for continuous improvement. You are able to work under pressure when needed and able to make independent decisions regarding patient 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.
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 Wasim Anwar at +45 3079 6766.
Deadline
25th 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 Bagsværd.
Jobbet er oprettet på vores service den 26.7.2019, 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
- Bagsværd
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