11/09/2022 updated

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Consultant, Medical & Scientific Writer, Pharmacovigilance, Drug Safety

Saint Louis, France
Worldwide
Ph.D.
Saint Louis, France
Worldwide
Ph.D.

Profile attachments

CV - Joseph Gut

PharmacovigilanceGeneticsMedical Writing
Genetics in Human Drug Safety, Pharmacovigilance, Regulatory, Scientific & Medical Writing, Preparation of Registration Document acc. ICH- and REACH- Guidelines, Writing and Bloging towards Patient- and General-Public.

Languages

GermanNative speakerEnglishGoodFrenchGood

Project history

Preclinical Assessor / Le ad GLP-Inspector

Swissmedic: Agency for Therapeutic Products
* Delivered quality assessments of studies.
* Completed preclinical and clinical drug safety assessments, identifying and analysing risks, assessing FIM
preclinical safety dossiers.
* Undertook GLP-inspections and devised associated reports, adhering to ICH-guidelines and regulations on
GLP, GMP, GCP and GVP.
* Led Pharmaco and toxicogenetic predispositions of subpopulations and single individuals for drug-induced
disease and serious ADRs.

Founder & Senior Consultant

Theragenomics Associates (TGA)
* Established company, a glocalized interactive social network and knowledge base, specialising in
theragenomic, personalized medicine and individualized drug safety.
* Wrote 900+ blog posts to support activities, covering topics of theragenomics, personalized medicine, and
individualized drug safety, posted in English, French and German languages to reach a global audience
(www.thasso.com ).
* Individualized drug safety and personalized medicine - University of Basel.

CEO/CSO

TheraSTrat AG
* Identified underlying mechanisms and pathways, leading to drug-induced disease and ADRs.
* Delivered evidence-based prediction of ADRs in subpopulations and single patients.
* Studied drug-metabolism, drug-drug interactions and the influence of endogenous, dietary, environmental,
occupational and behavioural compounds on drug-induced disease.
* Provided prediction of in vitro and in vivo correlations in molecular animal and human toxicology.
* and in drug disposition.
* Oversaw drug safety related knowledge ontologies and knowledge management systems.
* Built and developed strong global customer relations.
* Presented complex scientific and business topics.

Group Leader

Novartis Pharma

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