Regulatory Affairs Specialist@ Pivotal
Toulouse, Occitanie, France
Evelyne Comte
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FlashIntel GPTEvelyne Comte is an expert resource in clinical trials and the pharmaceutical industry, with 17.1 years of experience. She has worked on various clinical and epidemiological studies, from design to final report. Evelyne is skilled in ICH-GCP and has a strong understanding of the current regulations and ICH-GCP. She has worked on multicentric projects in international environments, including observational, pharmacoepidemiologic, and multicentric projects. Evelyne has held positions such as Freelance Regulatory Affairs Specialist, Regulatory AFFAIRS Specialist, Project Manager, and Clinical Research Professional. She is a highly experienced professional in the field of clinical research.
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About
Expert resource for dealing with conduct of clinical and epidemiological studies, from the design phase through to the final report of the project, in accordance with the current regulations, ICH-GCP and by complying with sponsor/company SOP. I have been involved in PHASE I, II, III, IV of clinical development, in observationnal, pharmacoepidemiologic, multicentric projects, in an international environment within the following roles: - STUDY START-UP SPECIALIST - REGULATORY AFFAIRS SPECIALIST - PROJECT MANAGER - BUDGET AND CONTRACT NEGOTIATOR - CLINICAL RESEARCH ASSOCIATE - METHODOLOGIST - DATA ABSTRACTOR - DATA MANAGER - BIOSTATISTICIAN - MEDICAL WRITER
...See MoreWork Experience
Regulatory Affairs Specialist
Pharmaceutical Manufacturing
Evelyne Comte's Professional Milestones
- Clinical Research Consultant (2014-01-01~): Provided expert insights and recommendations to help clients navigate clinical trials.
- Regulatory Affairs Specialist (2016-06-01~): Improving regulatory compliance and achieving regulatory compliance through effective negotiating tactics and research and analysis.
Skill
Clinical Trials
Pharmaceutical Industry
Clinical Development
Clinical Research
Cro
Gcp
Regulatory Submissions
Contract Negotiation
Regulatory Affairs
Project Management
Epidemiology
Pharmacoepidemiology
Pharmacoeconomics
Observational Studies
Biostatistics
Methodology
Protocol Design
Data Analysis
Data Management
Ctms
Oncology
Interventional Cardiology
Hiv
Gynecology
Gynecologic Oncology
Obstetrics
Asthma
Vaccinations
Pediatrics
Informatisation Des Essais Cliniques
Recherche Clinique
Oncologie
Certification
Colleagues
Jose Javier (JJ) Garcia
deputy general manager pivotal
Lourdes Huarte Osácar
Senior Vice President Regulatory & Clinical Operations
Ibrahim Farr
Chairman | Chief Executive Officer
Jose Viéitez
director médico cro pivotal en pivotal
Andrew Obrien
Vice President Sales Americas
Other Named Evelyne Comte
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Evelyne Comte works for Pivotal
Evelyne Comte's role in Pivotal is Regulatory Affairs Specialist
Evelyne Comte works in the industry of Pharmaceutical Manufacturing
Evelyne Comte's colleagues are Jose Javier (JJ) Garcia,Lourdes Huarte Osácar,Ibrahim Farr
Evelyne Comte's latest job experience is Regulatory Affairs Specialist at Pivotal
