succesful system business analyst with extensive analytical experience with system development and maintenance in a highly-regulated environment. motivated by working with system design, development and system Validation and all activities around this. i have worked with system development during the last 9 years which gained me experience with:
• urs development
• process design and implementation and periodic review
• lifecycle management
• gap Analysis
• data profiling
• idmp implementation
ability to develop and maintain close working relationships with other teams and departments. having the personal drive required to deliver a service that exceeds the expectations of colleagues and users through a well-organised and structured work ethic.
Senior ConsultantHørsholm, Denmark
Since June 2017
we pioneer new methodologies and technologies to keep companies compliant with new and constantly evolving governmental regulations and industry trends. and we help our clients bridge the gap between qa, it and line-of-business departments by aligning compliance across projects, systems and organizations. we know this makes an impact because we benchmark each and every service we provide. we use this information to pragmatically set the appropriate level of compliance for each individual customer.
Epista Life Science is a consultancy dedicated to continuously improving regulatory compliance. We turn compliance obstacles into business opportunities for our clients and for the industry.
We pioneer new methodologies and technologies to keep companies compliant with new and constantly evolving governmental regulations and industry trends. And we help our clients bridge the gap between QA, IT and Line-of-Business departments by aligning compliance across projects, systems and organizations. We know this makes an impact because we benchmark each and every service we provide. We use this information to pragmatically set the appropriate level of compliance for each individual customer.
Application SpecialistSeptember 2014 --- April 2017
part of the support team for e-rims (register) responsibilities • system support for 150+ users • user Training • support project activities • support Validation activities • development and implementation of processes • Data Analysis and issue resolution • kpi's • idmp implementation
Senior Pharmacovigilance Systems OfficerAugust 2012 --- March 2014
work as part of a support team responsible for delivering a high-quality, customer-focused service and participating in relevant working streams for a major upgrading project of adverse event tracking system responsibilities: • perform user acceptance Testing (performance/functionality) • user Training and user support to pv system users • development of sops and working instructions • implementation of new regulatory or business requirements • e2b Testing (inbound and outbound) • support pv end users with system issues • input into system enhancements and fixes • support safety database audits or inspections • maintain database Documentation • support database dictionary/library activities • input into generation of queries to support ad-hoc queries results: • Training of 200 users before go-live • succesful e2b test finalisation with 12 authorities within the set timelines
Regulatory Information ManagerAugust 2008 --- August 2012
work as core Member of a major implementation project delivering a high-Quality System, supporting process and user Training. system maintenance and participate in a project to comply with the new evmpd legislation. development and operation of support organisation responsibilities: • drive system Change Management and lifecycle activities • implementation and Documentation of system changes • development and review of system design documents • test Planning, execution, test Verification and Documentation and reporting • development and implementation of new processes • drive periodic review of processes • system support for 150+ users • Data Analysis and issue resolution • development of traning materials and user Training • development and Testing of SQL searches in cooperaton with it • preparation for and assistance in audits and inspections results: • finalisation of system implementation within the set timelines, succesful implementation of high-Quality System, compliant with system standards and 21 CFR Part 11 with migrated data, associated processes and roll-out to 150+ users. Compliance with evmpd guideline per 2 july 2012.
Assistant, Packaging DepartmentMarch 2001 --- December 2001
Assistant, GCP and ProcessesJanuary 2000 --- December 2000
ApproachabilityCoordinationProblem solvingResult Oriented
Skills and Expertise
Analytical skills Write protocolsCreate standard operating procedure (SOP)Design IT solutionsTrain StaffValidate data
Bachelor's degree in Accountancy from Koninklijk Atheneum, Turnhout in 2001
in from St Dimpnalyceum in 1993