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
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.
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.
Quality and Compliance Management
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Holds experience working with data, modelling and statistical analyses within the cancer research industry. Assisting Compliance Manager experience.
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.
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
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.
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.
Holds more than 25 years experience from the pharmaceutical industry working with Manufacturing, IT and automation in Quality Assurance, Compliance, Implementation projects, Training and Audits.
Charlotte has performed the role as ITQA, ITQC, Validation responsible, trainer, IT process owner, Lead Auditor and is highly specialised in GxP. She has several years of experience within the different systems used in the entire life cycle, incl. different MES systems, SAP (ATTP for Serialization), RIMS, Oracle Clinical for Data Management and Medical Device PLM system. Charlotte is also an experienced auditor.
Pharma Business Consultants
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
Junior Consultants - Students
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.
Pharma IT student worker, master student at the Danish Technical University in Biomedical Engineering.
Student assistent in Compliance Team.
Pharma IT student worker, master student at the University of Copenhagen in Health Informatics.
Experience as PMO for large SAP roll out project.
Pharma IT student worker, bachelor student at the Copenhagen Business School, studying IT and Economy. New to life science.
Drug safety, Data Management and Medical Writing
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 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.