Clinical Safety Administrator Zaventem, Belgium
Since July 2014
Adverse Events and complaints reporting Working in the international division for the Clinical Department. Adverse Event reporting to the different Ethics Committees and Competent Authorities within Europe, North Africa and Asia and internal complaints reporting. Main challenge: very sharp timelines. Approach & main achievements • Reviewing and querying (if necessary) of Adverse Events Case Report Form (CRF) within timelines. • Reporting Adverse Events in a MEDDEV table according to the requirements (CIP / health authorities). • Submission of complaints linked to the Adverse Event within timelines. • Tracking of the submissions (MEDDEV, Complains, Progress Periodic Report, …) • CRF deletion requests management. • Contact with Clinical Project Leader and collection of Countries specific regulatory requirements for the different kind of studies (class II-IV). • Data reconciliation: assessment of seriousness and device/procedure relationship in accordance Adjudication committee meetings results. • Project team meetings. • CRF discrepancies handling. • Periodic Progress Report (PPR) preparation. Technical environment & methodologies • Oracle Clinical Database(View RDC CRF, Custom report). • Field Event Reporting Database(complains, reports). • Excel (tracking, MEDDEV). • Organize the day/week. • To reach objectives in given timelines.
August 2011 --- June 2014
Mother Child Care Working in Neonatology, Maternity, Delivery Room, and Maternal Intensive Care Unit at various hospitals in Brussels area. Missions were day to day with shifting hours. Protocols and care habits were different between some units and hospitals; therefore a fast and calm adaptation was required to be able to manage in case of emergency. Approach & main achievements • Participate to nurse meeting. • Fill in the patient’s file everyday. • Prenatal care. • Perinatal care. • Post-natal care. • Neonatology care. • Preparation of required equipment (safety, sterile,...) Technical environment & methodologies • Have a good point of view of the situation (identify the patient, know the history,…). • Stay calm in any situation. • Listen the complaints of the patient and always (re-)analyze the situation, to be able to prevent problem and/or react fast to an emergency. • In delivery room, always update the board and the team with the “new” information of your patients (cervix dilatation, possible problem pending,…). Therefore if you need help or go in operative-room, the team can easily take over. • Plan and organize the cares for the different patients (mother and/or baby) to be able to do everything within the shift.
January 2014 --- March 2014
Customers support and bank products sales. Working in an agency in Uccle. We had to advice and help people who came at the reception and sell them our services. The principal challenge was that every trainings and communications were in Dutch. Approach & main achievements • Organize the daily morning meeting: print the useful information’s for the tasks of the day for every employee. • Present during daily meeting the big amount transfer which were not usual, to be able to react/prevent fraud. • Working at the reception: welcome clients, help clients (advice on products, take action in case of “lost bank card”, exchange with other currencies, …), order money, fill in the money dispenser. • Working “in the office” : open current and/or saving account, sell insurance, sell safe deposit boxes (in bank vault), sell credit card, … Technical environment & methodologies • Use of a special banking program for all operations. The use of this program was taught in trainings. • Safety concern: identify client with their ID, never do something on behalf of the client with somebody else, except if an authorization was done in the bank with the client for this person. • Money safety concern: always respect the opening hours of the bank vault, and close it if there is no worker in the agency during the lunch. When “money transportation” is coming, take care of the money as fast as possible (store it where it has to be). • Client satisfaction concern: listen to them and try to identify their needs to be able to give the best advice.
Student Support in Biostatistics
July 2012 --- August 2013
Help students during practical work Working at school to help students who needed a refresh in Biostatistics and Epi-info (statistical analysis program).This was for the first year Master students in Public Health School during summer 2012 and summer 2013 for the biostatistics courses and in April-May 2013 for the courses of Epi-Info. The principal challenge was to re-explain the courses in a different way to help students to understand the theory, and be able to apply this one. Approach & main achievements • Review of the exercises and theory for the course of Biostatistics. • Practical help for students who needed a review of the statistical analysis program "Epi-Info". Technical environment & methodologies • Time management: allow time for students to ask question, motivates them to answer questions from other, and correcting “wrong answers” before moving to the next exercise. • Students management: try that each student participates : go to the black board (or principal computer) to resolve the exercises, motivates them to ask their questions, and react to questions. • If the same question comes back: explain in a different way, not only with different words but also use of analogy, comparison to help them to see how it’s supposed to be done. • Prepare in advance the resolution of the exercises, and review the entire theory, in case of question about something else.
August 2011 --- November 2012
Please see description for Reflex Interim.
AdaptabilitySelf-disciplineOrganizationInterest in knowledgeEfficiencyCuriosityCollaborationAuthenticityApproachabilityAttention to detailSociability
Skills and Expertise
Analyze data Control data Interact with nurses Interact with physicians Interpret data Report data Search literature on clinical trialsAdverse event reportingAssess adverse reactionsAssess subject safetyClinical data collectionComplete case report form (CRF)Data analysisData codingData entryData verificationDetermine statistical analysis Develop clinical hypothesesDevelop clinical trial protocolsEnsure good clinical practice (GCP)Ethics committee submissionsSerious Adverse Event (SAE) ReconciliationStatistical analysisWork under specific instructions
Master's degree in Public Health (epidemiology & biostatistics) in Biostatistique from Université libre de Bruxelles in 2013
Bachelor's degree of Midwifery in Sages-femmes from Haute Ecole Libre de Bruxelles Ilya Prigogine in 2011