Passionate Safety Specialist with experience in clinical trials, research, health project management, risk assessment, quality improvement, and dental treatment, focused on enhancing organizational safety standards and ensuring regulatory compliance in organisational safety standards and ensuring regulatory compliance.
Übersicht
7
7
years of professional experience
7
7
years of post-secondary education
Berufserfahrung
Safety Specialist
Safety Project & More GmbH
Hirschberg an der bergstraße
2024.04 - 2025.11
As a Safety Assistant, I supported pharmacovigilance and regulatory activities by assisting with DSURs, PSURs, and Signal Management Reports, maintaining GVP-compliant safety databases, and ensuring accurate reporting to the EMA, MHRA, and FDA. I performed case processing, MedDRA coding, data reconciliation, and supported medical device vigilance activities through incident data review, documentation, and compliance with EU MDR reporting requirements. I also contributed to SOP improvements, collaborating with Regulatory Affairs and Clinical R&D.
Office Assistant
Safety Project & More GmbH
Hirschberg an der bergstraße
2023.03 - 2024.03
My responsibilities include writing reports, organising and maintaining documents, and providing administrative support to various committees and authorities. I also assist in conducting internal and external audits, managing office facilities, and supporting other organisational functions.
Dentist | Quality Coordinator | Researcher
Khartoum Dental Teaching Hospital
Khartoum
2019.01 - 2022.08
As a dentist, I was responsible for offering patients vital oral healthcare services.
In addition to my background in dentistry, I have experience as a researcher and public health professional. My work has focused on areas such as epidemiology, oral and mental health, child health, gender-based violence (GBV), climate change, and health systems and policy. I have contributed to high-quality research, data analysis, and policy development, emphasising strengthening health systems and promoting evidence-based, sustainable public health interventions.