Team

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.

Computerized System Validation, ISEB Foundation and ITIL Foundation
HeidiNoerTroelsenR
Senior Pharma Consultant
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
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 13 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: CISA, ITIL Foundation, Computer Validation Manager, Lead Auditor and SAFe Agilist
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, Certified Veeva Vault Administrator
FieKrossdal
Pharma Consultant
Fie Krossdal

Cand. Scient. in Health Informatics.

2 years of experience within IT compliance assisting Validation Track Lead in IT implementation projects.

Experience with RPA(programming and processes) projects as well.

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, Lead Auditor and SAFe 4 Agilist
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.

Foundation ISTQB Certified Tester programme
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.

GAMP (Computer System Validation), Certified Tester, Trained in risk-based testing, ISTQB foundation
Junior Pharma Consultant
Anders Winkel

Anders Winkel has 9 years of work experience doing research at the University of Copenhagen. He has had experience in using a broad suite of analytical software such as Graph Pad Prism, SensorTrace Suite, PicoLog and GIS.

In Pharma IT he is acting as assisting compliance manager and he has also led several process analysis initiatives.

GAMP 5
Principal Pharma Consultant
Anders Jakobsson

Anders Jakobsson holds in total 36 years of experience in Software quality and development. Anders holds more than 25 years of experience in the pharmaceutical industry working with QA, regulatory compliance, supplier audits and QMS development and roll-out.

Anders has experience in different areas of the pharmaceutical business such as GCP, GVP, GMP, GDP and medical device. Computer systems support in areas such as Production automation, Laboratory automation, ERP incl. serialization, Pharmacovigilance, Clinical Trials, Regulatory Affairs.

SAFe 4 Agilist, ISA S88 and S95, ISO 9000, 21 CFR Part 11, GMP Training Courses: manufacturing, distribution, auditing, batch release

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.

SAFe 4 Agilist, PRINCE2, ITIL, GDPR Practitioner, CIPP/E 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 Veeva Vault Administrator, Computerized System Validation/GAMP5 and GDPR Foundation
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, SAFe Agilist
Senior Pharma Consultant
Luise Søgaard Rosendahl

Holds extensive experience in the pharmaceutical industry working with IT Service Management, IT implementation projects, and IT Transition and Transformation programmes. Has played pivotal roles in IT system management organisations responsible for applications supporting Product Supply. Furthermore hands on experience as Business Consultant, IT Management SME, and Track Lead as part of a Management Consultancy organization.

ITIL®V3 Foundation, ITIL®V3 Intermediate RCV, NLP Business Practitioner, SAFe Agilist
Senior Pharma Consultant
Sara Halsskov

Holds more than 15 years of experience working in the pharmaceutical industry, working with IT systems and processes, primarily within Regulatory Affairs.  Sara has performed the role as Clinical Publisher, Regulatory Application Professional, eSubmission Manager, Senior QMS Professional/Project manager within Regulatory Affairs and Release Manager as part of System Management.

ITIL Foundation Certification, SOP Expert training, Writing effective standard operating procedures and other process documents (CfPIE), Computer Validation

Management Consulting

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. Søren has 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 Manager of several SAP ATTP implementations.

Project and Program Management certified in IPMA level C, PRINCE2 and MSP, General Data Protection Regulation (GDPR) certified from IBITGQ. SAFe 4 Agilist
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,  SAP ATTP rollouts, Production IT projects, IT QMS implementation and as Head of PMO.

Project and Program Management certified in PRINCE2, MSP, ITIL and Standford Advanced Project Management Program (SAPM). SAFe 4 Agilist
Senior Pharma Consultant
Jonas Ripa

Jonas Ripa holds more than 15 years’ experience in Project and Stakeholder Management from various projects and positions. Jonas has strong experience in infrastructure projects and software development projects, but also experienced in security as well as transitions projects.

He has been heading projects for major corporations from both customer and vendor side. He is highly specialised in Pharma and GxP critical systems. Jonas works comfortably is in the commercial and stakeholder management field. With an educational background in both the technical and commercial fields, he is confident in participating in complex dialogues in both areas.

PRINCE2 Foundation, ITIL Manager, GAMP, 21 CFR Part 11, Compliance and documentation on GxP critical systems

Pharmacovigilance Consultants

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

More than 13 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

Pharmacovigilance professional with 6 years of experience from the pharmaceutical industry. Experience from working in both headquarter and affiliate. Includes: Signal detection, literature monitoring, pharmacovigilance training, individual case safety report processing, including coding and narrative writing, scientific evaluation and reporting. Medical information activities; writing medical responses to health care professionals, direct costumer contact. Studying Master of Medicines Regulatory Affairs. 

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 systemst 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.

Pharmacovigilance Consultant
Maria Skou Andersen

Cand.pharm with five years of case processing experience in department of Global Pharmacovigilance. Experienced with handling adverse event reports including book-in, data entry, verification, reconciliation and MedDRA coding of spontaneous and study cases into the safety databases Argus and Empirica. 

EDMS system expert with Veeva implementation experience.

Certified Veeva Vault Administrator

Drug Development Consulting

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.

Senior Medical Writer
Kaushik Sengupta

Senior Medical Writing Consultant with over 8 years of experience from the pharmaceutical industry as a Senior/Expert Medical Writer. Has prepared numerous high-quality regulatory and research documents for leading global pharmaceutical companies. Typically, these documents have been based on Phase I–IV studies from most major therapeutic areas. Holds a Master in Dentistry from Canada and has pursued a PhD in epidemiology from Copenhagen University.

Data Management Consultant
Evangelos Kapris

Experienced Clinical Data Manager with experience within: CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk-based monitoring and data management oversight.

 

 

M.Sc. Data Mining
Data Management Consultant
Faiyaz Hussein

Is a Data Manager with 15 years of Clinical Research experience with respect to Project Management, Data management, eCRF and database designing, validation of IT systems, integration testing, reporting on varied EDC systems, electronic patient reported outcomes ePRO, edevices in diabetes care (Insulin pumps, CGM) and submission to Health Authorities with major pharmaceuticals.

21 CFR Part 11, GCP, Six Sigma Green, BASE SAS, Inform, Medidata Rave, Clintrial 4.4 EDC’s and OC/RDC
Senior Pharma Consultant
Torben Elhauge

Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area

With an offspring in Analytical development, Torben has a broad experience within all parts of the CMC area from development over validation and registration to GMP release of products.

Torben is experienced in working with Impurities, Stability, Specifications, Release of Investigation Medicinal, CRO’s and Tech Tranfer. Torben have assessed registration files at the Danish Medicines Agency and have written the analytical part of the registration file for several products.

Torben holds a master’s degree in chemical engineering.

GMP

Serialisation

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. Søren has 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 Manager of several SAP ATTP implementations.

Project and Program Management certified in IPMA level C, PRINCE2 and MSP, General Data Protection Regulation (GDPR) certified from IBITGQ. SAFe 4 Agilist
Senior Pharma Consultant
Jeppe Resen Amossen

Project manager and Serialisation SME with 9 years of experience in project management and more than 4 years of experience in the pharmaceutical sector. Experience from Pharmaceutical Production and Engineering.

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

 

SAFe 4 Agilist

Junior Consultants - Students

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
Simon Berner Borch

Pharma IT student worker, bachelor student at the Copenhagen Business School, studying IT and Economy. New to life science.