Regulatory, Safety and Customer Service (RSCS), Danish & Icelandic Affiliate
Ørestad, Denmark
Are you ready to play a pivotal role in ensuring product safety and compliance across Denmark and Iceland? Join us as a Safety Officer in the Regulatory, Safety and Customer Service (RSCS) department, where you’ll be at the heart of maintaining robust safety systems, handling critical safety and technical complaint cases, and supporting post-marketing activities. You’ll collaborate with internal and external stakeholders, manage essential documentation, and drive continuous process improvement, all while making a real impact on patient safety and regulatory excellence. This is your opportunity to grow in a dynamic, mission-driven environment, where unordinary drives change.
Your new role
As Safety Officer. You will maintain the Danish and Icelandic product safety and complaints process to meet legal requirements. You will also be Safety product responsible for obesity or diabetes and rare diseases including handling our product complaints
Your main responsibilities will include :
Interpreting and managing all product safety concerns including follow-up. Maintaining the safety records at Novo Nordisk affiliate and the transfer of safety data to Novo Nordisk Headquarter
Providing safety information to internal & external authorities and ensuring compliance with the adverse event reporting regulations and local processes
Safety information case handling, including follow up
Product complaint handling
Submission of relevant post-marketing cases to local health authorities
Managing the Safety database
This role contains several routine and monitoring tasks, it’s therefore important that you thrive working with such tasks daily
Local record manager
Updating local SOP’s
Your new department
You will join a small team made by passionate people that strives for excellence. In our team we continuously look at how we can optimize our processes, while still living up to obligations and legal requirements. We take pride in being the license to operate and we have the finger on the pulse based on having the direct contact to the customers. You will report directly to the Head of Regulatory Safety and Customer Service (RSCS).
Your skills & qualifications
To be successful in this role, we are looking for a candidate with the following qualifications :
You hold a bachelor’s degree in healthcare
Experience with pharmacovigilance (preferably)
You have a strong IT and database knowledge
You are fluent in written and spoken English and Danish
Proactive in reaching out to stakeholders
You are open minded, not afraid of asking questions, willing to learn new things and open to changes while keeping focus on the details
Officer • Ørestad, Denmark