Clinical Safety Professional

Category: Reg Affairs & Safety Pharmacovigilance

Location:Søborg, Capital Region of Denmark, DK

• Foreseeing which impact, changes to case handling related processes will have on other interlinked and related processes

• Participation in projects in Global Safety, or involvement in updates of standard operating procedures (SOPs)/working instructions where it is expected that you can act independently as Subject Matter Expert within the case handling field

• Dedicated clinical trials, where you will be main contact from case handling team to relevant stakeholders on larger clinical trials regarding specific safety issues

• Deadlines, cross-functional collaboration, and international communication will be part of your workday

• Involvement in the trial initiation phase for all types of clinical trials, where you will ensure trial set-up that supports case handling activities, and you will act as mentor for colleagues on these trials. Moreover, you will be part of our case management trial initiation group/forum
  
  

• B.Sc. degree and/or M.Sc. degree, registered nurse or equivalent within health science

• Documented +4 years-experience within pharmacovigilance and case handling.

• Preferably you have experience from a wide range of case handling related activities e.g. training responsibilities, subject matter expert experience or pharmacovigilance audit/inspection experience

• Extensive knowledge of pharmacovigilance principles as well as clinical trial regulations and regulatory requirements

• Experience with clinical trial and project management processes

• Familiarity with Novo Nordisk products is an advantage
• As a person you are self-driven, have excellent learning and analytical skills with a strong ability to communicate (professional proficiency in English), plan and coordinate multiple simultaneous activities. You work in a structured manner with a sense for details. You promote knowledge sharing and focus on ‘win-win’ solutions. You are diligent, show flexibility and are a good team player.