Data Integrity

Data Integrity is an increasingly important topic in the Pharmaceutical Sector. Partly because it is on the agenda with the regulatory bodies and a topic for inspections, resulting in a significant number of observations, FDA Warning Letters and EU Non-Compliance Reports.   Specializing in Pharma and IT we have been assisting preparing for a Pre-Approval …

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Pharma IT is welcoming three experienced consultants

Pharma IT is welcoming three experienced consultants

With this addition our team of experienced people and young talents is growing and making us stronger within quality, compliance and more knowledgeable within pharma business processes. Also these three profiles all have had experience working with – and validating SAP systems.

The three new consultants in Pharma IT are:

 

Ilhem Sahnoun Østergaard

Senior Consultant with over eighteen years’ experience in the Pharmaceuticals Industry. 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

 

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.

 

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

 

With this latest addition to the team we believe we have one of the absolutely strongest Compliance and Validation teams within Danish Pharma. See our team here – and don’t hesitate to contact us.

 

Pharma IT Experienced Pharmacovigilance Team

Pharma IT is expanding. The Pharmacovigilance Pharma IT team is growing and now counts 8 experienced Pharmacovigilance professionals. With the latest additions, Pharma IT can now assist with everything from Safety Data Entry to Safety Physician tasks – and everything in between. Alice Brinch Mørch has functioned as Qualified Person for Pharmacovigilance and Head of Drug …

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Pharma IT is growing – Experienced people and young talents

Pharma IT is growing. In Pharma IT we believe that we can improve the standards of pharma consulting, by challanging the way it is usually done. Pharma IT provides services within: Management Consulting Pharma Business Consulting Quality and Compliance Consulting IT Consulting If you need support do not hesitate to contact us – link Recently the following …

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Pharma IT – Attracting experienced people, educating young talents

Pharma IT is welcoming new experienced consultants. Our team of experienced people and young talents is growing and making us stronger within quality, compliance and more knowledgeable within pharma business processes. If you need support do not hesitate to contact us – link We are happy to welcome 3 new employees: Charlotte Bech Andersen – IT Program/Project Manager …

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Pharma IT Pharmacovigilance Team

Pharma IT is expanding. We are proud to announce that Ea Marie Holst and Louise Søgaard Nielsen has joined Pharma IT. Ea Marie Holst, Director of Pharmacovigilance has 12 years of experience as a pharmacovigilance professional. Experience from both headquarters and affiliates with all aspects of pharmacovigilance including; ICSR case processing and reporting, E2b reporting and testing, Signal …

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