Senior Safety SpecialistZaventem, Belgium
Since December 2017
Became Sr. Safety Specialist in December 2017.
Started as “St Jude Medical” employee (2016) – company was acquired by “Abbott”.
(Medical Device Safety) Adverse Events and Potential Complaints reporting.
Working in the international division for the Clinical Department. Main challenge: timelines.
Approach & main achievements
• Reviewing and querying (as applicable/necessary) assigned Case Report Form (CRF) within timelines and according to the Clinical Investigation Plan (CIP).
• Assessment of adverse event reports and analysis for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirement. Submission of potential complaints and MEDDEV/AE listings as per applicable legislation.
• Data reconciliation.
• Project team meetings.
• Collaboration with the CRA to ensure comprehensive information is available for full review and reporting.
• CRF discrepancies/requests management.
• Safety Plan preparation.
• Contribution to Safety section of Protocol design and Quality by Design meetings participation.
• Contribution to Safety section of submissions, reports, clinical summaries (as applicable/needed).
• Developing and facilitating safety training including creation of materials.
• Drafting AE narratives as required.
• Contribution with revision or writing of SOP/Instructions/Procedures and changes to support clinical department.
• Clinical Event Committee management (CEC charter, plan meetings, ...)
Technical environment & methodologies
• Oracle Clinical Database
• EPIQ database (for complaints)
• Excel (MEDDEV).
• Use of MedDRA (Medical Dictionary for Regulatory Activities)
• Organize the day/week.
• Reach objectives in given timelines.
• Stay up-to-date regarding the knowledge of global safety regulations, principles of device development and safety assessment of devices both on the market and in clinical development.
Safety Specialist II Zaventem, BelgiumJanuary 2016 --- November 2017
Pharmacovigilance Manager Brussels, BelgiumSeptember 2015 --- December 2015
Clinical Safety Administrator Zaventem, BelgiumJuly 2014 --- August 2015
Interim midwifeAugust 2011 --- June 2014
Customer AdvisorJanuary 2014 --- March 2014
Student Support in BiostatisticsJuly 2012 --- August 2013
Interim midwifeAugust 2011 --- November 2012
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
Training and Certification
Certified Clinical Research Professional in 2017 Certification