Mike Roberts Email
Director of Business Systems @ TMC Pharma Services Ltd
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Mike Roberts Location
- Bude, GB
Mike Roberts Work
- 2026 -now Director of Business Systems @
- 2025 -2025 Safety Systems and Validation Project Manager @
- 2023 -2024 Senior Manager, R and D Quality @
- 2009 -2023 PV Systems and Validation and CSV Consultant, Director @
- 2023 -2023 QA Consultant @
- 2022 -2023 Associate Director, Safety Systems @
- 2022 -2022 Project Manager @
- 2022 -2022 PV Systems Principal Specialist @
- 2021 -2022 Argus Safety Consultant @
- 2021 -2021 Interim Managing Director @
- 2019 -2021 Argus Safety Validation Consultant @
- 2019 -2019 PV IT Specialist @
- 2018 -2019 PV Systems Consultant @
- 2017 -2018 Argus Safety consultant @
- 2016 -2016 Director, IT Drug Safety Systems @
- 2015 -2016 Argus Safety Validation Consultant @
- 2013 -2015 PV Systems Consultant @
- 2011 -2013 Testing, Quality and Validation Business Lead - OASIS programme @
- 2007 -2011 Drug Safety systems consultant @
- 2004 -2006 Solution Architect @ Novartis
- 2002 -2004 Drug Safety Systems consultant @ Assured Information Systems
- 2002 -2004 Argus Safety consultant @ Actelion
- 2000 -2004 Argus Safety consultant @ Relsys International
- 2003 -2004 Argus Safety consultant @ Helsinn
- 1998 -2000 Safety systems developer and DBA @ Glaxo Wellcome
- 1995 -1997 Drug Safety systems consultant @ Glaxo Wellcome
- 1994 -1995 Oracle consultant @
- 1991 -1994 Software Engineer @ Praxis Systems
Mike Roberts Education
- Polytechnic of Wales
1st Class (Computer Studies)
1987-1991 - The Rawlett School 1980-1987
Mike Roberts Skills
- Computer System Validation
- 21 CFR Part 11
- GxP
- Validation
- Pharmacovigilance
- SDLC
- Requirements Analysis
- Oracle
- Business Analysis
- Drug Safety
- Argus Safety
- Quality Assurance
- Testing
- Change Control
- PL/SQL
- Informatics
- ICH-GCP
- Clinical Development
- GCP
- Lifesciences
- CRO
- Clinical Data Management
- Clinical Trials
- Data Management
- EDC
- Regulatory Submissions
- Sop
- Regulatory Requirements
- Regulatory Affairs
- Pharmaceutical Industry
- FDA
- SQL
- User Acceptance Testing
- Data Migration
- Life Sciences
- Test Management
- U.S. Title 21 CFR Part 11 Regulation
- Consulting
- Ich Gcp
- Sales
- Strategic Planning
- Support
- Ich
Mike Roberts Summary
- Mike Roberts, based in Bude, GB, is currently a Director of Business Systems at TMC Pharma Services Ltd. Mike Roberts brings experience from previous roles at TMC Pharma Services Ltd, Moderna, Pink Octopus Consulting and Truliant Consulting. Mike Roberts holds a 1987 - 1991 1st Class in Computer Studies @ Polytechnic of Wales. With a robust skill set that includes Computer System Validation, 21 CFR Part 11, GxP, Validation, Pharmacovigilance and more. Mike Roberts has 1 emails on RocketReach.
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Top TMC Pharma Services Ltd Employees
Gordon Cameron
Non Executive Director
Nottingham, GB
Simon Estcourt
CEO TMC
United Kingdom
Carol Woodward
Chief Operating Officer
United Kingdom
Gary Coleman
Director of Business Development
Tucson, AZ, US
Phoevos Hughes
Head of US Operations
Chapel Hill, NC, US
Bjorn Sternberg
Director Of Clinical Services
Guildford, England, GB
Darnell James
Director of Regulatory Affairs
United Kingdom
Victoria Datsenko
Vice President Clinical Services
United Kingdom
Joe Lopez
Chief Financial Officer
United Kingdom
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