Project/Program/Service & Change Management
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 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.
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, ATTP rollouts, 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.
1,5 years of experience within IT compliance assisting Validation Track Lead in IT implementation projects.
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.
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.
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.
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.
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
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.
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.
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
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 Danish Technical University in Biomedical Engineering. 3 years of experience within life science.
Pharma IT student worker, master student at the University of Copenhagen in Health Informatics.
Experience as PMO for large SAP roll out project.
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.