Senior Safety Operations Advisor in Global Safety

Ansøgningsfrist: 2017-10-29 Novo Nordisk

  • Regulatory
  • Denmark – Bagsværd

Do you want to play a key role in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk products? Are you looking for a position where you can use your medical knowledge and analytical skills? Then you may be our new Senior Safety Operations Advisor.

About the department
You will be part of a team of academic employees with different scientific and cultural backgrounds. The core activity of the department is to medically assess patient safety based on adverse event reports and product quality issues to ensure compliance with regulatory requirements globally. The Safety Operations Advisor team is part of Global Safety and is situated in Bagsværd.

The position
As a Senior Safety Operations Advisor you will be responsible for evaluating the impact & consequences of disease conditions, interpreting diagnostic results and for identifying differential diagnosis based on individual safety cases reported from clinical trials as well as products on the market.

Furthermore you will review clinical trial and non-interventional study protocols to ensure adequate collection of relevant safety information according to regulatory requirements and Novo Nordisk procedures. The responsibility includes training of monitors & investigators globally with regards to safety reporting and chairing cross functional groups in clinical trials within Global Safety.

The position likewise holds responsibility for medical evaluation of the potential risk to patients in relation to product quality issues, and in potential recall situations.

You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional collaboration, and international communication will be part of your workday.

Qualifications
You have a Master’s degree in medicine or health science and solid understanding of medical concepts, disease processes and scientific methodology. Prior experience within pharmacovigilance is an advantage.

As a person you are responsible, well-organised and have a positive attitude to challenges. You have a high degree of flexibility, a good sense of urgency and cope well under pressure while still maintaining your good sense of humour. You are a strong collaborator and a dedicated team player who thrives in a multicultural environment and are good at establishing contact and collaborating with stakeholders.

You are fluent in English both written and spoken (company language).

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 Merete Chur Fischer at +45 3077 7675.

Deadline
29 October 2017.