Safety System Professional in Global Safety - Denmark
Safety Operations (SO) Maintenance & Support team is looking for a Safety System Professional for an exciting job with a high degree of individual responsibility in a dynamic atmosphere.
About the department
- The SO Maintenance & Support is one of the functional teams in Safety Operations within Global Safety.
- Global Safety is part of the Research & Development organisation and is responsible for the global handling and reporting of adverse events to authorities, and the surveillance of the safety and quality of our company clinical development and marketed products.
- The SO Maintenance & Support team consists of 7 highly engaged team members with diverse professional backgrounds, responsible for operating and maintaining the Global Safety database Argus and ensuring optimal business benefits for end-users in various projects.
- The team works across departments in Global Safety and liaises with external stakeholders.
- The team operates in a dynamic environment reflecting the increasing demands from numerous clinical trials and regulatory authority requirements.
- Your main responsibility is to contribute to the development and continuous improvements of the Global Safety database Argus.
- This includes business configuration e.g. country specific product licenses, code lists, clinical trials and auto scheduling rules for regulatory reporting.
- You will, among other things, be analysing changes in regulatory requirements, performing impact assessments and gap analysis towards the Argus database and its related business processes.
- Your role in projects will be to provide subject matter expert input regarding regulatory requirements, business processes and requirements to IT systems.
- You will be performing informal and formal testing, updating standard operating procedures and guidelines and participating in implementation and end-user training.
- Together with your colleagues, you will also be supporting end-users on a daily basis.
- This entails front-end trouble shooting, incident reporting and identification of improvement initiatives.
- You have a relevant university degree e.g. in Natural Science, IT or Engineering and have experience working with relational databases, preferably Argus or Aris Global.
- You have been working within the field of Pharmacovigilance or Regulatory Affairs and you have experience in analysing and optimising business processes.
- Experience with system testing, SQL, impact assessment, stakeholder management and project team work is an advantage.
- The role requires strong analytical skills including the ability to focus on details and adherence to standards while maintaining a balanced business perspective.
- The capability to understand and connect regulatory requirements, business processes and functionality of IT systems is essential.
- The desired candidate has a structured approach to tasks, shows commitment, initiative and flexibility and has a good sense of humour.
- You are open-minded and enthusiastic, a strong team player who can take responsibility and finalise assigned tasks.
- You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.
Working with us:
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.