Stuhr Consulting
Dr Thomas Stuhr
Dr Thomas Stuhr, owner of Stuhr Consulting, has almost 20 years of experience in the pharmaceutical industry in the areas of pharmacovigilance and quality management. Through many years of work, both in global pharmaceutical companies and in consulting and project management at a service provider, Dr. Stuhr has a wide range of local and global pharmacovigilance systems, which he has supported in the implementation and maintenance and managed successfully.
Taking on responsible pharmacovigilance functions such as local safety officer, phase plan officer, QPPV, information officer in medium-sized and global pharmaceutical companies and the management of global pharmacovigilance units were just as much a part of this as "hands-on" tasks as an auditor, trainer and process analyst.
By participating in pharmacovigilance inspections and managing them on the company's side, Dr Stuhr has in-depth experience with the evaluation of pharmacovigilance systems by various European authorities.
Curriculum Vitae Thomas Stuhr
-
2018 Foundation of Stuhr Consulting / FreelancerListenelement 1Strategic development and support in the implementation of a global PV system with over 40 country organizations for a newly founded MAH Interim management of pharmacovigilance in the US branch of a company Joint development and support in the implementation of an AI component in a pharmacovigilance workflow Takeover of QPPV Responsibility for conducting GVP audits as lead auditor
-
2014-2018 Head Global Pharmacovigilance/Qualified Person responsible for Pharmacovigilance (QPPV)/Stufenplanbeauftragter MEDA GmbH & Co. KGListenelement 2Management of global drug safety and direct reporting line to the board, authorized officer Management of an international team of approx. 60 employees spread over the headquarters and more than 40 subsidiaries in their own country organizations Strategic development of the global PV system Representation of the company to external parties such as authorities, companies and contractual partners Organization and management of official inspections (e.g. EMA, BfArM, MHRA, MPA, SUKL, AGES etc.) Implementation of GVP audits as co-auditor
-
2013-2014 Functional Head Quality Management and Compliance Services YES Pharmaceutical Development Services GmbHListenelement 3Management and development of the Quality Management and Compliance Services department Management of a team of QM specialists Management of customer-specific projects from the entire spectrum of QM and QA areas (e.g. auditing, CAPA handling, SOP creation, gap analyses, inspection preparations, system descriptions, etc.) Setup and Maintaining relationships with customers, authorities and associations. Representation of the company in project tenders Conducting GVP audits as lead auditor
-
2012-2013 Manager Quality Management und Compliance Services YES Pharmaceutical Development Services GmbHListenelement 4Analysis and evaluation of pharmacovigilance systems, e.g. through auditing Gap analysis of existing systems and identification of solution strategies, as well as their implementation, among other things, by leading project-specific matrix teams from various areas Economic evaluation of PV systems Inspection preparations and implementation of official inspections SOP creation Introduction of new Legislation (GVP) in the PV system of various customers Conducting GVP audits as lead auditor
-
2010–2012 Functional Head Pharmacovigilance YES Pharmaceutical Development Services GmbHManagement and development of the drug safety department in cooperation with two other functional heads Management of a dedicated team of 8 employees Management of customer-specific projects from the entire spectrum of drug safety (e.g. ICSR management, PSUR creation, RMP creation, SOP creation) Implementation of GVP Audits as Lead Auditor Building and maintaining relationships with customers, authorities and associations. Representation of the company in project tenders
-
2007-2009 Local Safety Officer Daiichi Sankyo Deutschland GmbHDevelopment and independent management of a department for drug safety Creation and establishment of WIs and SOPs in order to reflect and adapt the specifications of the AMG and Vol. Information officer Daiichi Sankyo Deutschland GmbH: Coordination of the content of approval texts Implementation of approval texts in SmPC and PIL Legal evaluation of advertising materials according to AMG and HWG
-
2005-2007 Sales Representative / Key Account Management Daiichi Sankyo Germany GmbHSupport for opinion leaders, cardiologists, orthopaedists, as well as established APIs Organization and implementation of training events Support in the implementation of phase IV studies Evaluation of scientific work for marketing purposes, as well as collaboration in the creation of discussion documents for the field service
-
Studies/PhD1997-2001 Studies in biology at Saarland University 2001-2002 Diploma thesis (with distinction 1.2) - Research area: Evolution of the human retrovirus-K(HML-2.HOM) in the human genome 2002-2005 Doctorate (magna cum laude) - Research area : Investigations of polymorphic genes of human retroviruses/functional analysis of retroviral genes