The Pharma IT team

We are proud to present the Pharma IT team. Our team consists of very experienced consultants within Pharma and IT mixed with young potential.

We priorities Quality and set High Standards for our self. We will be looking forward to working with you, so feel free to contact us.

  • Project/Program/Service and Change Management
  • Quality and Compliance Managemen
  • Pharmacovigilance Business Consulting
  • Pharma Business Consultants
  • Pharma Trainee Consultants
Project/Program/Service and Change Management 

 JakobJuulRasmussen

Jakob Juul Rasmussen

IT Program/Project Manager with 16 years of experience with in pharmaceutical, finance and public sector. Experience with infrastructure, service delivery management, application development, SOA and SAP projects.

Project and Program Management certified in IPMA level A, PMP, MoP, PRINCE2, MSP and Professional SCRUM master

Contact

 SorenWinkelS

Søren Winkel

IT Program/Project Manager with more than 10 years of experience running business critical projects and programmes. I have more than 6 years’ experience in running projects in the pharmaceutical sector.

Focus on Serialisation and the many new legislations being implemented in key markets.

Project and Program Management certified in IPMA level C,  PRINCE2 and MSP, General Data Protection Regulation (GDPR) certified from IBITGQ.

Contact

CBAD 2017 BW

 

Charlotte Bech Andersen

IT Program/Project Manager with 15 years of experience from the IT industry within fields of Program management, Project management and IT service management. Experience from the Pharmaceutical industry and Public sector. Experience with a wide range of projects in software development, transition projects, infrastructure & operations projects and projects in service and process implementation. GxP and non GxP.

 

Project and Program Management certified in PMP, PRINCE2, ITIL and certified negotiator. Holds a Master degree in International Business, a MITS degree from Copenhagen Business school of Executive Management Institute and courses from Henley Business School.

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 MogensHogh

Mogens Høgh

IT Program/Project Manager with 16 years of experience with in the pharmaceutical sector and 30 years of experience within IT. Experience with infrastructure, service delivery management and application development.

Project Management certified in PMP, ITIL and ISTQB Advanced Test Management, General Data Protection Regulation (GDPR) certified from IBITGQ.

 Quality and Compliance Management

 HeidiNoerTroelsenR

Heidi Noer Troelsen

QA and Compliance Specialist with +20 years of experiences within the Pharmaceutical industry. Hands on experienced as a laboratory Technician, IT supporter, Project Manager, IT QA, Quality Specialist, QA, IT Compliance Consultant, Auditor, QA People Manager and Quality Director.

Certified in GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, Quality Risk Management, Audit Management and ITIL

Contact

 DanAndersenR

Dan Andersen

30 years of pharma experience from multiple area of business and levels of responsibility with a constant focus of delivering compliant solutions. Hands on experienced as a Security Manager, QA, Compliance Specialist, Validation Specialist, Project Manager and Process Technician.

Certified in CISSP (IT security), CISA (IS Audit), CISM (Security Manager), GxP, Computerized System Validation, 21 CFR Part 11 / EU Annex 11, LEAN and ITIL

 StineKristensenR

Stine Kristensen

More than 10 years of experience in the biotech and/or pharmaceutical industry within IT compliance, quality management and system administration. Experience in Quality Management Systems projects and related training.
Validation lead for several GxP projects. Experience with planning, requirements (documentation in particular), test design, conducting tests, reporting and collaborating with IT departments and external vendors.

 DorteJuulR

Dorte Juul

More than 10 years of experience with IT compliance. Working as Validation Track Lead in projects and as Business Consultant in system operation and maintenance. Primarily with corporate GxP systems within the Regulatory, Quality and R&D area.

Certification: ITIL Foundation, Computer Validation Manager and Lead Auditor

BenedikteMarieDueBW

 

Benedikte Marie Due

More than 10 years of experience with IT compliance. Working as Validation Track Lead in IT implementation projects and as Business Consultant in system operation and maintenance.

Experience primarily with corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certified in Computerized System Validation/GAMP5

 GitteHebsgaardR

Gitte Hebsgaard

Technical Compliance Specialist with 20 years of experience with IT within Pharmaceutical Industry.
Datamatiker with experience as IT QA and Compliance Specialist. Experience from participating in two FDA audits and vendor audits.

Certified in Infrastructure Qualification, Computer System Validation, GAMP5 and ITIL

FieKrossdal

 

Fie Krossdal

Pharma IT compliance consultant, master student at Copenhagen University within Health Informatics. 2 years of experience within life science from student position and project work at larger pharmaceutical company in the Copenhagen area.

Certified in Computerized System Validation/GAMP5

 

 Pharmacovigilance Consultants

 

EAH 2017 BW

Ea Marie Holst - Director of Pharmacovigilance

11 years of experienced as a pharmacovigilance professional. Experience from both headquarters and affiliates with all aspects of pharmacovigilance including; Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training in the companies and outside, E2B reporting and testing, ICSR case processing and reporting. Experience with Medical Information and Promotional Material Review.

Contact

 MieAltermannSørensenBW Mie Altermann Sørensen

Pharmacovigilance specialist with 5 years of experience with processing of ICSR's. Having worked with various safety databases e.g. AERS, Argus, Aris Global, Empirica and SBI. In addition, 1.5 years of experience within Medical Information.

Master in Pharmaceutical Sciences.

Louise Søgaard Nielsen

Louise Søgaard Nielsen

Senior Pharmacovigilance Consultant has 10 years of experience as a pharmacovigilance professional. Experience with all aspects of pharmacovigilance including; ICSR case processing and reporting, Signal Detection, PSUR and DSUR writing and submission; Risk Management Plans and maintaining and building quality management systems.

CAAR 2017 BW

Camilla Ardal

Senior Pharmacovigilance Consultant has 10 years of experience as a pharmacovigilance professional. Experience with all aspects of pharmacovigilance including; ICSR case processing and reporting, Signal Detection, PSUR and DSUR writing and submission and Risk Management Plans.

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Lærke Nielsen

Pharma IT student worker, bachlor student at the Danish Technical University in Medicin and Technology.

 Pharma Business Consultants

 

PeterNoesR

Peter Noes

Information technology professional with more than 10 years of experience from the pharmaceutical industry. Extensive business understanding and experience from IT projects mainly within the areas of Regulatory Operations - eSubmission (eCTD), Electronic Documents Management Systems (EDMS), Regulatory Information Management Systems (RIMS), XEVMPD and IDMP. Broad experience with project management, system administration and system implementation and with establishing and optimizing business processes within GxP areas.

Certified in Computerized System Validation/GAMP5

 JRK 2017 BW

 

Jannie Rosenkjær Melbye

Senior Pharma Consultant with 11 years’ experience within document/information and application management. 17 years’ of experience in the field between IT and business. Experience with GxP, application management - especially document management, functional and technical support, test and validation. Furthermore, experience within ITIL, vendor management, communication with end users, transition and application management.

 

Certified in ITIL, Computerized System Validation/GAMP5

KristianEstebanLorentzen

Kristian Esteban Lorentzen

SAP ATTP consultant with more than 5 years of experience in the Life Science industry. Specialized in Supply Chain Management, Serialization and Track & Trace. Experience from several serialization projects including end-to-end implementation of SAP ATTP and SAP AII/OER.

 Pharma Trainee Consultants

 

 JulieVitoftKiersgaardR

Julie Vitoft Kiersgaard

Pharma IT student worker, MSc. Library and Information Science student at Copenhagen University. More than 4 years of experience in the pharmaceutical industry from earlier student position and maternity cover position at a Danish Pharmaceutical Company. Experience mainly lies in the information technology area such as advanced information searches (e.g. ProQuest Dialog), database management, information monitoring and IT knowledge.

Certified in Computerized System Validation/GAMP5

 MartinKristensenR

Martin Kristensen

Pharma IT student worker, master student at Aalborg University, Copenhagen within IT Science. 0,5 years of experience within life science from student position.

Certified in Computerized System Validation/GAMP5 and SCRUM Fundamentals

MathiasNørbækJohansen

Mathias Nørbæk Johansen

Pharma IT student worker, master student at the Danish Technical University in Biomedical Engineering. 3 years of experience within life science.

Certified in Computerized System Validation/GAMP5