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Summary

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

• 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

• xevmpd

• 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.

Experiences

Current Experience

  • Senior Consultant

    Hørsholm, Denmark
    Since June 2017

    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.

    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.

Past Experience

  • Application Specialist

    September 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 

  • QA Officer

    April 2014 --- August 2014
    Quality Assurance and Validation manager for erp (SAP) implementation in the nordic countries.

  • Senior Pharmacovigilance Systems Officer

    August 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 Manager

    August 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.

  • Clinical Finance Coordinator

    December 2007 --- August 2008
    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

  • Clinical Trial Assistant (CTA)

    March 2007 --- November 2007
    responsibilities: • support of the clinical Project Manager during design and conduct of Clinical trials

  • Pharmacovigilance Assistant

    August 2002 --- February 2007
    • database surveillance, Analysis and user Training and Data entry • e2b submission • reporting Compliance

  • Assistant, Packaging Department

    March 2001 --- December 2001

  • Assistant, GCP and Processes

    January 2000 --- December 2000

Personality

Self Assessment :
ApproachabilityCoordinationProblem solvingResult Oriented

Knowledge

LinkedIn Assessment :
Computer System ValidationValidationPharmacovigilanceEnd User TrainingWriting and Implementing ProcessesClinical researchRegulatory submissionsSOPPQ Test ManagerPharmaceutical IndustryRegulatory RequirementsSecond line user supportDatabase Administration, businessEVMPDCRF Part 11 complianceSoftware Documentation21 CFR Part 11Clinical trialsChange ControlCRO

Skills and Expertise

Self Assessment :
Analytical skills Write protocolsCreate standard operating procedure (SOP)Design IT solutionsTrain StaffValidate data

Education

  • Bachelor's degree in Accountancy from Koninklijk Atheneum, Turnhout in 2001
  • in from St Dimpnalyceum in 1993

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
Danish
Full Proficiency
English
Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Compliance Manager
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Denmark

Others

Driving License
  • Yes

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