I am a devoted person, co-operative, situate myself quickly into cases and problems, flexible and social. I am skilful adept in establishing positive relationships with customers, pharmaceutical representatives/manufacturers, medical professionals, health organizations, etc. I have high knowledge of various drugs, medicines and diseases, and proficiency within budget and finances. Respected leader, able to train and manage staff to deliver top performance. As regards work; I enjoy working in team first and foremost, and can also work independently if essential or necessary.
Executive Summary / Key Competencies:
- Ensuring compliance to EU GxP regulations and the requirements of the Responsible Person outlined in the EU GDP
- Writing/review of QA documents such as working instructions, SOPs, working procedures, templates etc.
- Literature review
- Individual case safety report handling
- Aggregated reports (PSUR, RMP, ACO, PADER)
- Signal detection
- MedDRA coding