MD Vigilance Expert – Pharmacist – Complaint & Vigilance Manager Haasrode, Belgium
Since April 2010
A pharmacist with more than 13 years experience in the quality assurance, regulatory affairs & cGMP requirements within the pharmaceutical and medical device industry. Since 2008, I joined Terumo Europe where roles of increasing responsibility have been held in maintaining quality, risk management and clinical evidence systems. In my current position, I’m fully responsible for global complaint handling and vigilance system. I’m also a lead auditor for medical device quality system regulations.
Document Analyst – Responsible Clinical Evidence Haasrode, Belgium
February 2008 --- April 2010
Tasks as Documentation Analyst:
- Maintenance of quality system procedures (creation, review).
- Support Regulatory submissions (notified body, FDA... ).
- Conducting internal and external audits (ISO 9001, ISO 13485, 21 CFR part 820, and Japan Pharmaceutical Affairs Law).
- Maintenance of Design History Files and support Modification sheet procedures.
- Creation and maintenance of risk management system for medical devices in accordance with ISO 14971.
- Responsible for conduction of clinical simulated use studies for medical devices.
Tasks as Responsible Clinical Evidence:
- Clinical evaluation of medical devices via literature search studies. This include creation of search protocol, conducting the search in clinical databases and databases of competence authorities, data selection and evaluation, data analysis, creation of literature search reports and finally creation of clinical evaluation reports.
Junior qualified person & validation coordinator Hamont-Achel, Belgium
March 2005 --- February 2008
Tasks as Junior Qualified Person:
- Batch record review prior to release.
- Handling of internal deviation including root cause analysis, and implementation of preventive and corrective actions.
- Complaints handling including investigation and implementation of preventive and corrective actions.
- Creation and evaluation of annual product reviews.
- GMP Field trainer.
- Auditor for internal and external audits.
- Quality control team leader responsible for training, supervision, planning and evaluation of the quality controllers and laboratory employees.
- Compliance and regulatory affairs coordinator (pharmaceutical inspection, local authorities, external audits and FDA inspection).
- Implementation & follow up of corrective actions.
- Member of the training and documentation group.
Tasks as Validation Coordinator
- Responsible for the creation and execution of all SOP’s & validation protocols including: Validation Master Plan (VMP), User Requirement Specifications (URS), Design Qualifications(DQ), Risk & Impact Analysis (RIA), Installation Qualifications (IQ), Operational Qualifications (OQ), performance qualifications (PQ) for the equipments and utilities, Retrospective Validation, Analytical Test method Validation, Cleaning Validation and Computer System Validation.
- Responsible for the environmental monitoring system and all monitoring activities.
Analytical thinkingAdaptabilityCollaborationEfficiencyFlexibilityProblem solving
Pharmaceutical Industry Medical devices
Skills and Expertise
Analytical skillsInteract with regulatory stakeholdersConduct post-marketing surveillance studyDesign post-marketing surveillance studyEvaluate post-marketing surveillance studyDevelop training materials
Master in Pharmaceutical Sciences from Alexandria University in 1998