My Picture My name is Piotr Nowicki and I'm the founder of PragmaLog. Having studied Medicine at the Medical University in Gdansk in Poland, I complemented my education with a degree in Medical Informatics at the University of Applied Science in Berlin. It was always my keen interest to combine medicine and informatics in meaningful and pragmatic way.
Following this idea I began to work as Java programmer developing coding modules for Hospital Information Systems. After 2 years of extensive programming I decided to work in the pharmaceutical industry.
I started to gain my experience in Data Management departments (Phases I to IV) where I faced the problems when dealing with collection, analysis, reporting and presentation of large amounts of data.

In the Phase I Data Management Unit I was responsible for :

  • Support of business process analysis
  • Collection and analysis of user requirements.
  • Development of validation strategy for the Phase I Data Management System

In the Clinical Data Management Departments (Phases II - IV) as Clinical Data Manager , my responsibilities included:

  • Supervision of Data Management project team members
  • Supervision of contract negotiations with CRO with regard to Data Management activities
  • Management of outsourced Data Management processes
  • Set up of control procedures for collaboration with the CRO (quality control and performance metrics)
  • Ensure compliance with study and project timelines
  • Provision of Data Management documentation and appropriate guidance and training of the CRO
  • Support of study protocol generation
  • Check of the data base structure to ensure compliance with study protocol
  • Set up of the CRF/DCF workflow
  • Establishment of handling procedures for additional study data
  • Coordination of data transfers
  • Set up and performance of AE / SAE reconciliation process
  • Set up of the coding environment and performance of coding (MedDRA, Harts, WHODD, ATC)
  • Performance of medical reviews
After 3 years of work I moved to the Pharmacovigilance department where I realized the roles of Project Manager and Information Retrieval Specialist.

In the role of the Project Manager my main task was the implementation of integrated system and methodologies for automatic Ongoing Safety Monitoring and Safety Signal Detection. My responsibilities included:

  • Workout of the project concept
  • Creation of the project plan (including statement of work, resource assignment, responsibility matrix, communication plan, project schedule, cost estimates, risk analysis, control procedures, continuous improvement process etc.)
  • Set up of the project team
  • Collection of business requirements and process analysis
  • Supervision of contract negotiations
  • Management of the computerized system validation procedures
  • Organization of training and support procedures
  • Writing of SOPs and Working Procedures

In the role of Information Retrieval Specialist my responsibilities included :

  • Generation of specialized Product Ongoing Safety Monitoring Reports
  • Implementation and usage of Quantitative Signal Detection algorithms (e.g. PRRs with CIs)
  • Preparation of Product Group specific Data Analysis Plans
  • Training of medical Product Experts with regard to cumulative data analysis and interpretation of Quantitative Signals
  • Close collaboration with Product Experts for assessment of appropriate product's safety profile

Additionally, in 2006, I received my Certificate in Pharmacoepidemiology and Pharmacovigilance at LSHTM in London.

After successful completion of the project in the drug safety department (2007) I decided to work as independent consultant providing my services in the area of Pharmacovigilance. The main scope remains the introduction and improvement of signal detection and safety monitoring systems, preparation of systems for internal and external audits, implementation of signal detection algorithms and procedures, assessment and interpretation of quantitative 'signals' and explorative data analysis.

Education

Dates Degree attained or qualification Educational institute or facility
1999-2002 Medical Computer Scientist Technische Fachhochschule Berlin - University of Applied Sciences (Germany)
1992-1998 Medical Doctor (M.D.) Medical University of Gdansk (Poland)
Additional Education
2006 Certification in Pharmacoepidemiology & Pharmacovigilance The London School of Hygiene & Tropical Medicine

Work experience

Dates Employer Business operating area / Functions
Oct 2007- Present Self-employed Pharmacovigilance, Signal Detection, Explorative Data Analysis, Project Management, IT Systems
Jan 2005- Sep 2007 Bayer Schering Pharma Project Manager for the introduction of integrated drug safety monitoring and signal detection system. Pharmacovigilance Information Retrieval Specialist
Mar 2003- Jan 2005 Schering AG Clinical Data Manager (Phases II - IV)
Nov 2001- Feb 2003 Schering AG Clinical Data Manager(Phase I),MedDRA Medical Coding Expert, Support of the introduction of a Phase I Data Management System
Jul 1999- Nov 2001 Gesellschaft fur Medizinische Datenverarbeitung Medical Software Engineering, Development of Coding Modules for Hospital Information Systems

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