Team

Project/Program/Service & Change Management

JakobJuulRasmussen
PARTNER
Jakob Juul Rasmussen
+ 45 24 34 26 55

IT Program/Project Manager with 16 years of experience within the pharmaceutical industry, finance and the 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
PARTNER
Søren Winkel
+45 26 78 02 06

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.
CBAD 2017 BW
PARTNER
Charlotte Bech Andersen
+ 45 61 98 27 05

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.

Holds a Master degree in International Business, a MITS degree from Copenhagen Business school of Executive Management Institute and courses from Henley Business School.

Project and Program Management certified in PMP, PRINCE2, ITIL and certified negotiator.
Director, Project Management Consultant
Peter-Emil Iversen
+45 28 68 78 31

More than 10 years of experience from the Pharmaceutical industry. Experienced in bridging IT Programme- and Project Management within the pharmaceutical industry. Strong references from some of the largest IT Programmes in Danish Life Science.

Experience as PM from Serialisation Projects, ATTP rollouts, IT QMS implementation and as Head of PMO.

Project and Program Management certified in PRINCE2, MSP, ITIL and Standford Advanced Project Management Program (SAPM)

Quality and Compliance Management

Senior Pharma Consultant
Tine Falk

More than 15 years of experience with implementation projects and system operation. She is highly specialized in GxP. She has performed in roles such as Compliance Consultant and Test Manager.

Tine also have 5 years of experience as SAP System Manager in a highly complex environment.

HeidiNoerTroelsenR
Director
Heidi Noer Troelsen
+45 30 69 07 24

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
DanAndersenR
Senior Pharma Consultant
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
DorteJuulR
Senior Pharma Consultant
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
Senior Pharma Consultant
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
StineKristensenR
Senior Pharma Consultant
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.

Certification: ITIL Foundation, Computer Validation Manager and Lead Auditor
FieKrossdal
Pharma Consultant
Fie Krossdal

Cand. Scient. in Health Informatics.

1,5 years of experience within IT compliance assisting Validation Track Lead in IT implementation projects.

Certified in Computerized System Validation/GAMP5
Senior Pharma Consultant
Ilhem Sahnoun Østergaard

Senior Consultant with over eighteen years’ experience in the Pharmaceuticals Industry.
Active senior level professional with extensive experience in Computer System Validation (CSV) and in Test Management.
Background includes: Management of IT Compliance, IT Project Management in GXP area, Computer System Validation, IT Quality Assurance, Qualification of the GXP IT infrastructure, advising/consulting with IT associates on matters pertaining to compliance, conducting Training in GXP, Management and Administration of GXP applications.

Certified in Computerized System Validation/GAMP5
Senior Pharma Consultant
Nini Redøhl

More than 10 years of experience with IT compliance, Quality Management and System Administration within the Pharmaceutical industry. Working as Validation Track Lead in IT implementation and upgrade projects.

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

Certification: ITIL Foundation, Computer Validation Manager and Lead Auditor
Senior Pharma Consultant
Jesper Damborg Bendtsen

Holds more than 17 years’ experience in the pharmaceutical industry working with validation and compliance. Jesper’s experience spans IT implementation projects, validation, compliance projects, and IT system administration.

Avoiding non-Compliance in Packaging Operations; Validation of Ventilation (HVAC); QA and System Manager for GxP critical IT systems; Qualification of cooling facilities
Senior Pharma Consultant
Arash Gohar

Senior Automation & IT Engineer with expertise in design, configuration, test and commissioning of fully integrated BMS/EMS platforms, energy metering and power management, central plant equipment in both GxP and non-GxP environments. Test and Qualification of MES system

eTIMS, GDP, HSE, Advances in Syncade and SIMATIC S7
Junior Pharma Consultant
Lea Elsborg Olsen

Holds experience working with data, modelling and statistical analyses within the cancer research industry. Assisting Compliance Manager experience.

Senior Pharma Consultant
Mette-Marie Thyge Nøigaard

15 years of experience with in pharmaceutical sector working with processes and quality.Experience with implementation of process optimization, large and small changes in Pharmaceutical organizations, management of stakeholders on all levels and development, implementation and execution of training programs.

ISO 9001 Lead Auditor
Senior Pharma Consultant
Pernille Juel Schjørring

Holds more than 16 years’ experience in the pharmaceutical and Medical device industry working with compliance documentation, validation, test best practices and testing of both GxP critical and no-critical IT-systems

SAFe® Agilist Certification Exam, PRINCE2 ITIL®V3, ISTQB® Certified Tester, Advanced Level, Test Manager, GAMP, ISEB, 21 CFR Part 11.
Junior Pharma Consultant
Sara Hamilton

Holds two years’ experience in the pharmaceutical industry working with pharmacovigilance and two years’ experience working with data, quality improvement of data and implementation projects within the hospital sector. Assisting Compliance manager experience.

Pharma Business Consultants

Senior Pharma Consultant
Steen Lindebjerg

IT Program/Project Manager and Senior Pharma Consultant within Identity Management and GDPR with more than 20 years of experience from the IT industry within Pharmaceutical, Finance, Food and Public sectors. Experience with wide range of projects and operation in Infrastructure, IAM & Security, Application development, process optimization and IT service management.

PRINCE2, ITIL, EU-GDPR and Certified Engineer in Microsoft Infrastructure MSCE and Nowell Network CNE
Senior Pharma Consultant
Peter Noes

Information technology professional with more than 13 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
Senior Pharma Consultant
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

Pharmacovigilance Consultants

Director of Pharmacovigilance
Ea Marie Holst
+ 45 30 22 23 21

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.

Senior Pharmacovigilance Consultant
Mie Altermann Sørensen

Ms.c in Pharmaceutical Sciences. 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.

Senior Pharmacovigilance Consultant
Louise Søgaard Nielsen

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.t a larger pharmaceutical company in the Copenhagen area

Senior Pharmacovigilance Consultant
Kristine Kornøe

Experienced in clinical and postmarketing safety after working 6 years as a Drug Safety Advisor in a large danish HQ. Experience include: Signal Detection, PSUR/PBRER and DSUR writing and submission; Risk Management Plans; maintaining and building quality management systems; pharmacovigilance training, E2B reporting, ICSR case processing and reporting.

Senior Pharmacovigilance Consultant
Maria Skou Andersen

Recently graduated pharmacist with four years of data entry experience in Global Pharmacovigilance. Experienced with ICSR handling including book-in, data entry, reconciliation and coding of spontaneous and study cases into the databases Argus and Empirica.

Serialisation

Senior Pharma Consultant
Troels Skakfjord Magnussen

IT Consultant with more than 5 years of experience

Working within the field of Supply Chain Integrity, especially Pharma Serialisation and Product Tracking and ERP system integration. Several years of experience in working with GxP. Extensive knowledge about the Track & Trace concepts and the Pharmaceutical Supply Chain from

Manufacturing, Packaging to Distribution. Excellent functional understanding of SAP ATTP and Serialisation including customizing for customer specific needs

Serialisation Projects at Novo Nordisk, LEO Pharma, Lundbeck and Biogen

Junior Consultants

Pharma Consultant
Julie Vitoft Kiersgaard

Cand. Scient. Bibl. / in Information Science.

6 years of experience in the pharmaceutical industry. Experience mainly lies within the information specialists aspects (such as advanced search strategies, monitoring literature, database and information management and analyzing) and IT compliance aspects (such as system implementation and documentation. Especially, the safety database Argus). In addition, experience with various tasks within pharmacovigilance in different larger pharmaceutical companies.

Certified in Computer System Validation/GAMP5
Junior Consultant
Signe Winther Hasler

Pharma IT student worker, master student at the Danish Technical University in Biomedical Engineering.

Student assistent in Compliance Team.

Junior Consultant
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
Junior Consultant
Anders Bom

Pharma IT student worker, master student at the University of Copenhagen in Health Informatics.

Experience as PMO for large SAP roll out project.

Data Management

Data Management Consultant
Jens Sørensen

Clinical Data Manager with pharmacy background and 18 years of experience from the pharmaceutical industry. Experience as both insourced and outsourced consultant with all aspects of clinical data management including; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SAS and SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk based monitoring and data management oversight.