Margit Raunkjær Andersen Email & Phone Number

Copenhagen Metropolitan Area

• Ensuring patient safety for Semaglutide in clinical development and on the market:
• ️ Signal detection and signal management
• ️ Responsible for clinical trial closure activities on the FLOW trial
• ️ Critical analysis and medical evaluation of emerging aggregate safety data
• ️ Contribute to regulatory submission documents, periodic aggregate reports, and health authority interactions
• ️ Project lead for a team of advisers investigating a new safety signal, ensuring timely delivery of results and communication to stakeholders

Copenhagen, Capital Region Of Denmark, Denmark

• Maternity cover in the Danish affiliate working with pharmacovigilance and complaints handling on all Novo Nordisk products marketed in Denmark and Iceland.
• ️ Collection and handling of safety data and follow-up (ICSRs)
• ️ Handling of technical complaints
• ️ Optimization of processes
• ️ Literature surveillance
• ️ Submission of SUSARs from clinical trials

Aalborg, North Jutland, Denmark

• I have been a central part of the company's QA&RA team that ensures compliance to the Medical Device Regulation and applicable standards. The company has been certified in quality management and information security.
• ️ Development of the regulatory strategy based on applicable legislation and guidelines
• ️ Regulatory approval in EU
• ️ Design control
• ️ Clinical evaluation and post-market surveillance
• ️ Risk management

Amphi Systems is a small MedTech company providing prehospital software solutions to the healthcare sector. During the internship, I have been introduced to the Medical Device Regulation and participated in several quality assurance procedures in order to ensure compliance to ISO 13485, ISO 27001, and ISO 27701. Furthermore, I got experience in navigating.

• The student teachers are a self-propelled unit, which manages different tasks at Aalborg University such as assisting in teaching activities, improving teaching material, planning, and holding dissection courses.
• ️ Project management
• ️ Communication and teaching
• ️ Coordination

Mentoring children and young adults in courses such as mathematics and Danish while focusing on motivation and learning styles.

• Nursing and observation of patients at the hospital. Working at the hospital brought the following competencies:
• ️ Communicating with patients
• ️ Coordinating with healthcare professionals
• ️ Insight on the workings of the hospital sector

Master'S Degree, Medicine With Industrial Specialisation: Biomedicine

The master provides knowledge on current perspectives and challenges in modern medicine, and competencies are developed in designing and.

Bachelor'S Degree, Medicine

The bachelor provided detailed knowledge of the human body: anatomy, physiology, histology, biochemistry, immunology, pharmacology.