Work experience for 18 years in pharmaceutical industry in positions both at affiliate and regional level. Experience with clinical trial data management, clinical trial study management systems (randomization), drug safety & medical information. Experienced (8 years) lab technician in different research labs (mutagenicity, cytogenetics, histology, ecology). Several years of people management experience (small groups of 4 people). Very system, IT minded. Always striving in getting the best out of IT systems. Dynamic, pragmatic, very customer focused. Person with integrity. Rather a “doer” than a “thinker”.
Business Unit Manager Pharma Ternat, Belgium
August 2016 --- November 2016
- Define campains for quick wins with regards to turnover within Pharma BU
- Find oppportunities with existing products/solutions
- Marketing activities for the promotion of pharma products
Medical Information & Drug Safety Team Leader
June 2011 --- February 2016
Leading the team of Medical Information & Dug Safety Associates and Assistants (4 people). Performance management of team members. Set team objectives together with Medical Director. Ensure replies (phone, email, CRM) to medical questions from customers (HCPs, patients) in Luxembourg and Belgium. Support in medico-legal review of promotional materials within Belgium and Luxembourg. Case management of spontaneous & trial adverse events for Belgium and Luxembourg. Link with the responsible person for complaints and counterfeiting cases. Ensure labeling communication (SPC/PIL) towards internal (marketing) stakeholder and external ones (Pharma.be, AFMPS, etc..).
Medical Information & Drug Safety Associate
February 2004 --- June 2011
Ensure replies (phone, email, CRM) to medical questions from customers (HCPs, patients) in Luxembourg and Belgium. Support in medico-legal review of promotional materials within Belgium and Luxembourg. Case management of spontaneous & trial adverse events for Belgium and Luxembourg. Link with the responsible person for complaints and counterfeiting cases. Ensure labeling communication (SPC/PIL) towards internal (marketing) stakeholder and external ones (Pharma.be, AFMPS, etc..).
European CT-SMS Team Leader/ European Help-desk Coordinator
February 2001 --- January 2004
Recruit, train and manage CT-SMS team (4 people). Work with Corporate CT-SMS team on definition and documentation of business procedures, training and support procedures. Ensure proper training of CT-SMS users in Europe. Participate at and ensure Europe business representation in change control board. Marketing of CT-SMS to European affiliates. Budget and Resource planning for CT-SMS in Europe. Define and manage support structure in Europe. Manage relations with external service providers. Effective communication with all stakeholders. .
Clinical Trial Study Management System Project Assistant
January 2000 --- February 2001
Assist in training and coaching CT-SMS helpdesk employees. Ensure & Verify CT-SMS user satisfaction. Maintain system support tools. Ensure monthly metrics are available. Enable implementation of Corporate CT-SMS studies in Europe. Make sure CT-SMS software is installed at European affiliate user’s PC before start of patient enrolment. Follow up on installation of new software releases. Ensure proper training for European Lilly CT-SMS users and European site IVR users.
Clinical Investigation Assistant
August 1997 --- December 1999
Data Management of registration trials with Electronic Data Capture system. Assisting in on-site Source Data Verification.
First technician, special projects
January 1989 --- January 1997
Free University of Brussels, lab for cytogenetics. Worked on European Research projects. Experience with several mutagenicity tests, cytometry. In situ hybridization, histological- and immunostaining. Free University of Brussels, Lab ecology, HPLC determination of chlorophyll in samples from the Schelde in order to study the phytoplankton summer blooms.
AdaptabilityAnalytical thinkingAttention to detailAuthenticityCollaborationCommunicativeDiligenceOptimismEfficiencyFlexibilityInterest in knowledgeTrustService orientedResult Oriented
Diabetes Labtechnician21 CFR Part 11Adverse Events (AE)CAPACell biologyChange ControlChange ManagementClinical researchClinical Trial Management System (CTMS)CoachingComplianceDrug Safety and PharmacovigilanceDrug regulatory authoritiesDue DiligenceeCTDElectronic Data Capture (EDC) ElectrophoresisEthics submission and approval processGeneticsGXPHPLCIVRSMedical affairsMicrosoft ExcelMicrosoft PowerpointMicrosoft OfficeMicrosoft WordMolecular & Cellular BiologyOutsourcingpeople managementPharmaceutical IndustryPhase IIIPhase IVPresentation SkillsPrinciples and ethics of clinical researchPharmacovigilanceMultilingualOutlookProblem SolvingRegulatory affairsSafety reportingSAPSearch literature on clinical trialsSerious Adverse Event (SAE)Standard Operating Procedure (SOP)Team Leadership
Bachelor in Science in Pharmaceutical and Biological Laboratory Techniques from Erasmushogeschool Brussel in 1989