Application Specialist - Regulatory Information Management System at Leo Pharma
Copenhagen Area, Capital Region, Denmark
September 2014 to Present
April 2014 to August 2014
Senior Pharmacovigilance Systems Officer
August 2012 to March 2014
London, United Kingdom
Nycomed: a Takeda Company
Regulatory Information Manager
August 2008 to August 2012
Clinical Finance Coordinator
December 2007 to August 2008
Clinical Trial Assistant
March 2007 to November 2007
August 2002 to February 2007
Janssen, Pharmaceutical Companies of Johnson and Johnson
Assistant, Packaging Department
March 2001 to December 2001
Janssen, Pharmaceutical Companies of Johnson and Johnson
Assistant, GCP and Processes
January 2000 to December 2000
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 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
What company does An Van Clemen work for?
An Van Clemen works for Leo Pharma
What is An Van Clemen's role at Leo Pharma?
An Van Clemen is Application Specialist
What industry does An Van Clemen work in?
An Van Clemen works in the Pharmaceuticals industry.
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 5,5 years which gained me experience with: • URS development • Test Management and documentation verification • Writing of validation documentation • Process design and implementation and periodic review • Lifecycle management • Change control and documentation • Development of training materials and User Training • GAP analysis • Regulatory compliance • 21 CFR part 11 • EVMPD 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.Application Specialist @ 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 From September 2014 to Present (1 year 2 months) BallerupQA Officer @ Quality Assurance and Validation Manager for ERP (SAP) implementation in the Nordic countries. From April 2014 to August 2014 (5 months) CopenhagenSenior Pharmacovigilance Systems Officer @ 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 From August 2012 to March 2014 (1 year 8 months) London, United KingdomRegulatory Information Manager @ 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. From August 2008 to August 2012 (4 years 1 month) Roskilde, DenmarkClinical Finance Coordinator @ Responsibilities: • Implementing new finance strategies • Designing and implementing finance reporting processes and reporting tools and training of relevent staff • Monthly budget reporting to Management and Controlling From December 2007 to August 2008 (9 months) Clinical Trial Assistant @ Responsibilities: • Support of the Clinical Project Manager during design and conduct of clinical trials From March 2007 to November 2007 (9 months) RoskildePharmacovigilance Assistant @ • Database surveillance, analysis and user training and data entry • E2B submission • Reporting compliance From August 2002 to February 2007 (4 years 7 months) DenmarkAssistant, Packaging Department @ From March 2001 to December 2001 (10 months) Beerse, BelgiumAssistant, GCP and Processes @ From January 2000 to December 2000 (1 year) Beerse, BelgiumBachelor's degree, Accountancy @ Koninklijk Atheneum, Turnhout From 1998 to 2001 St Dimpnalyceum From 1987 to 1993 An Van Clemen is skilled in: Computer System..., Validation, Pharmacovigilance, End User Training, Writing and..., Clinical Research, Regulatory Submissions, Sop, PQ Test Manager, Pharmaceutical Industry, Regulatory Requirements, Second line user support, Database..., EVMPD, CRF Part 11 compliance, Software Documentation, 21 CFR Part 11, Clinical Trials, Change Control, CRO
Introversion (I), Sensing (S), Thinking (T), Perceiving (P)
1 year(s), 8 month(s)
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