Speciality: PBRER/DSUR and risk/benefit assessments, hence the pharmacovigilance part of pharmaceutical industry.
Medical Writer Kampenhout, Belgium
Since February 2017
I'm a medical writer writing PBRER/DSUR and risk/benefit assessments, hence the pharmacovigilance department of pharmaceutical industry. Experience gained at GSK and UCB.
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Drug Safety Scientist Lasne, Belgium
August 2009 --- September 2013
I worked for UCB, GSK and other pharmaceutical companies as a drug safety consultant:
- Writing of PSURs and DSURs, update RMPs for products like Cervarix and Rotarix (over 2000 cases per report)
- Working with pharmacovigilance databases like Empirica Trace and Argus
- Writing of responses to authorities
- Update company SOP to comply with changes in EU laws regarding pharmacovigilance
- Literature review with regard to drug safety using ScienceDirect
- Knowledge and working experience with WHO Drug Dictionnary and MedDRA
- Review of AE/SAE report database to detect inconsistencies or discrepancies at entry from clinical trials, spontaneous sources or licensee partners, for serious and non-serious reports.
- Approve and comment reported AE/SAE cases
- Reporting of AE via Eudravigilance
- Screening job applicants for Keyrus Biopharma PV department
- Contact with new PV clients
- Search outstanding information regarding disease states, concomitant drugs, or suspect drugs.
- Training fo junior drug safety scientists
Global Manufacturing Compliance Assistant
March 2009 --- July 2009
I was responsible for follow-up on the regulatory part of changes in production lines; I contacted the local departments.
January 2009 --- February 2009
My responsibilities included answering the phone, forwarding emails and creating an archieve for no-longer-used files.
January 2008 --- December 2008
I did replacments; I took over small animal vet practices during holiday, sick or maternity leave of the owner vet.
July 2002 --- September 2002
New products were tested for their effect on chitin synthesis inhibition in a pest insect, Spodoptera frugiperda through a radioisotope (prof. Dr. Ir. Guy Smagghe)
September 2001 --- February 2002
Insect Biocontrol Lab (Maryland, USA): work with insect stem cell cultures
Attention to detailCollaborationCompetitivenessCreative thinkingCritical thinkingCommunicativeEfficiencyIndependenceInterest in knowledgeOrganizationProactivityProblem solvingResult OrientedSelf-disciplineStrategic thinkingAdaptability
Skills and Expertise
Create SOPs Interact with physicians Search literature on clinical trials Analytical skills Write papersAdverse event reportingAssess adverse reactionsComplete case report form (CRF)Conduct literature searchesData entryOral presentationPlan work to meet objectives and deadlinesPrepare responses to health authority queriesProvide trainingReport serious adverse events (SAE)Statistical analysisWrite documentsWrite final reports
Master in Veterinary Sciences from Ghent University in 2007
Master’s Degree in Biology - molecular from Vrije Universiteit Brussel in 2001
Training and Certification
Career Guidance by Core Talents in 2017 Training
Writing clinical protocol BioWin in 2010 Training
Body Language for Leaders Certification
Influencer Interview: Oprah Winfrey Certification
Sallie Krawcheck on Risk-Taking Certification
Shane Snow on Storytelling Certification
Top 5 Speed Reading Tips Certification
Expert has 2 publications (Will be avalible with full profile)