Project/Program/Service & Change Management

PARTNER

Jakob Juul Rasmussen

jajr@pharmait.dk

+ 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

sqwi@pharmait.dk

+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.

PARTNER

Charlotte Bech Andersen

cbad@pharmait.dk

+ 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

peei@pharmait.dk

+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)

Senior Pharma Consultant

Tine Falk

tifa@pharmait.dk

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.

Quality and Compliance Management

HeidiNoerTroelsenR

Director

Heidi Noer Troelsen

hnt@pharmait.dk

+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

dan@pharmait.dk

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

duhj@pharmait.dk

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

Senior Pharma Consultant

Benedikte Marie Due

bemd@pharmait.dk

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

sxkr@pharmait.dk

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

FieKrossdalR

Pharma Consultant

Fie Krossdal

fkro@pharmait.dk

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

ils@pharmait.dk

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.
Very good understanding of IT GXP systems and technology including: ARISg, FirstPoint (EDMS systems), LMS system, Rave (eDC). Oracle, SAP, Windows, VM ware and SharePoint.
Good experience in SAP ERP systems Validation and in other SAP validation projects (SAP Serialization and Track &Trace and SAP role authorization ), Qualification of SAP BO Reporting infrastructure.
Good knowledge of the following guidelines and regulations: 21 CFR Parts 11, GAMP5 and GCP. 
Good understanding of ITIL best practice 

Certified in Computerized System Validation/GAMP5

Senior Pharma Consultant

Nini Redøhl

nred@pharmait.dk

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

JulieVitoftKiersgaardR

Pharma Consultant

Julie Vitoft Kiersgaard

jvk@pharmait.dk

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

Pharma Business Consultants

JRK 2017 BW

Senior Pharma Consultant

Jannie Rosenkjær Melbye

jrk@pharmait.dk

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

Senior Pharma Consultant

Steen Lindebjerg

sl@pharmait.dk

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

noes@pharmait.dk

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

Pharmacovigilance Consultants

Director of Pharmacovigilance

Ea Marie Holst

eah@pharmait.dk

+ 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

mias@pharmait.dk

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

losn@pharmait.dk

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

Camilla Ardal

caar@pharmait.dk

cand.pharm.
More than 8 years of experience as a pharmacovigilance professional.
Experience with most aspects of pharmacovigilance including; ICSR case assessment and reporting, Signal Detection, writing of Periodic Reports and Risk Management Plans, and experience in Pharmacovigilance training internal in the companies and External.

Senior Pharmacovigilance Consultant

Kristine Kornøe

ktk@pharmait.dk

cand.pharm.

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

Alice Mørch

alm@pharmait.dk

cand. med
Experience as Qualified Person for Pharmacovigilance and Head of Drug Safety at a large danish HQ and more than 20 years of experience within the industry and 5 years of clinical experience after completing her MD. Holds diplomas in pharmaceutical medicine and specialized journalism

Pharmacovigilance Consultant

Maria Skou Andersen

msa@pharmait.dk

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

Kristian Esteban Lorentzen

krel@pharmait.dk

14 years of as a IT professional, primarily with Pharma. 

The last 5 years working exclusively with Serialization. Experience includes: SAP ATTP Track Lead, GS1/EPCIS Subject Matter Expert, Process Mapping and Process Guideline, Packaging line integration to SAP ATTP, CMO Integration, 3PL Integration, Serial Number Management, Master Data Management. Serialization Projects at ALK, Novo Nordisk and LEO Pharma

Senior Pharma Consultant

Troels Skakfjord Magnussen

trmu@pharmait.dk

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

Senior Pharma Consultant

Nicolai Sander Nielsen

nsn@pharmait.dk

7 years of experience in Supply Chain Management within the pharmaceutical industry. Previously engaged as Serialization Manager at LEO Pharma and Supply Chain PM at LEO Pharma as well as Novo Nordisk. Deep insight into serialization requirements and the impact on pharmaceutical supply chain. Overall accountable for ensuring all prescript drug manufactured by LEO Pharma or CMO’s are updated to support serialization, aggregation and reporting when a market requires so.

Serialisation Project at LEO Pharma and external Lecturer on Serialisation

Junior Consultants

Junior Consultant

Signe Winther Hasler

siw@pharmait.dk

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

Junior Consultant

Mathias Nørbæk Johansen

manj@pharmait.dk

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

Pharma IT student

Lærke Nielsen

lnie@pharmait.dk

Bachelor student at the Danish Technical University within Biomedical Engineering. Experience within Pharmacovigilane (Data Entry)

Junior Consultant

Anders Bom

abo@pharmait.dk

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

Experience as PMO for large SAP roll out project.