Senior Adviser for Safety Surveillance Device
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Søborg
- Clinical Development and Medical
- Søborg
Do you like to be a driving force in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk (NN) Medical Devices? And would you like to be part of one of the most skilled and advanced pharmacovigilance functions in Denmark? If you find this challenging you may be our new colleague.
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.
In the department we are more than 20 highly skilled pharmacovigilance experts having global responsibility for the signal detection and surveillance of all safety information for Novo Nordisk’s products that are currently marketed or under development. Within the department, we have the device surveillance/ vigilance team dedicated to safety data monitoring of NN Medical Devices and Digital Health portfolio.
The position
You will be primarily responsible for safety signal management activities which include critical analysis and medical evaluation of the emerging safety data reported for NN Medical Devices (including drug-device combination products) from clinical trials, marketed use and published literature.
You will play an important role in supporting the team to help build compliance to the EU Medical Device Regulation (MDR). You will be responsible for developing the Post-Market Surveillance (PMS) plans to support NN Medical Device product safety profile and clinical evaluation reports. Developing and maintaining the reference safety information and the labelling will also be a key responsibility. You will also be responsible for communication about the benefit risk assessment of NN Medical Devices via Periodic Safety Update Report (PSUR) as well as providing input to clinical trial protocols and clinical trial reports on collection and assessment of relevant safety information, as applicable.
Your job responsibilities may also include chairing a cross-functional safety committee and communication with internal and external stakeholders including regulatory authorities. You will be our safety representative in cross-functional teams and will work collaboratively with key team members in Device R&D, Medical & Science, Regulatory Affairs, Customer Complaints and other Global Safety functions in facilitating medical safety evaluations and decisions.
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.
Qualifications
You must have
- A university degree in life sciences (e.g. Medicine, Pharmacy or Biological Sciences etc.) preferably supplemented with documented scientific training e.g. PhD.
- Solid experience within pharmacovigilance and/or medical device vigilance in pre- and post-marketing setting and strong urge to specialise within pharmacovigilance.
- Ability to evaluate impact and consequences of disease conditions and medical interventions and knowledge of medical aspects of medical device safety
- Good understanding of data analysis, data evaluation and problem solving skills
- Excellent oral and written communication in English (company language)
- Knowledge and good understanding of national and international medical device regulations and regulatory guidelines - a plus
- Experience with working in multicultural teams - a plus
- Excellent experience of using MS Office
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 30796766
Deadline
20 August 2020
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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 5.8.2020, 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.
- Afdelingsleder
- Søborg
- Torsdag den 20. august 2020
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