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Thomas Bosio

Thomas Bosio

Certified

Regulatory Affairs Specialist - Drug Products and Medical Devices

Macopharma | France

Technologies

My Portfolio Highlights

My New Course

Exploratory Data Analysis in SQL

My New Course

Exploratory Data Analysis in Python

Aspiring Data Analyst ready to help companies making better data-driven decisions!

My Work

Take a look at my latest work.

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Soccer Through the Ages - An Analysis for the 2024 UEFA Euro Tournament

Python
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Predictive Modeling for Agriculture

SQL
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Sleep Health and Lifestyle

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Predicting Credit Card Approvals

certification

Data Analyst Associate

My Certifications

These are the industry credentials that I’ve earned.

Data Analyst

Associate

Other Certificates

Datacamp Data Analysis Associate

DataCamp Course Completion

Take a look at all the courses I’ve completed on DataCamp.

My Work Experience

Where I've interned and worked during my career.

Macopharma | Jun 2020 - Present

Regulatory Affairs Specialist

•Application and maintenance for marketing authorizations in Europe,Maghreb and Africa: elaborating responses document for the health authorities, updating dossiers, and applying for variations. • Application for national phases to local authorities in various countries in Europe. • Implementation of a pharmacovigilance system, coordination of pharmacovigilance activities with subcontractors in Europe (local QPPV, Deputy QPPV) and ensure weekly reconciliation for pharmacovigilance cases, product complaints, medical queries. • Review of artworks and promotional materials for drug products and medical devices (brochures, posters, etc.) in coordination with the marketing department and according to local requirements. Submission to the French authorities if needed according to mandatory timeslots. • Coordination of Price and reimbursement applications in various countries in Europe for drug products. • Implementation of the serialization system: coordination with IT and manufacturing sites, registration to NMVS, uploading data into the European Hub. • Redaction and update of procedures, job instructions, joint-operation guidelines, agreements, when requested according to the SMQ. • Application for Site Registration in France (“Etat des Lieux”). • Creation and implementation of e-learning/training modules: pharmacovigilance, promotional material compliance, pharmaceutical culture. • Regulatory support for internal and external audit.
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MINAKEM | Oct 2018 - Oct 2019

Regulatory Affairs Specialist

Application for CEP and US DMF and variations Implemantation of Risk Analysis fir ICH Q3D guidelines (elemental impurities) Site registration for France and Japan(SMF, MPUP, AFM) Redaction of change controls Impact analysis

LFB | Mar 2018 - Sep 2018

Regulatory Affairs Trainee - Europe Registration Department

- Variations Submissions (Nationales, MRP/DCP) - Update of the Plasma Master Files - Study of new guidelines (coreSPC, excipients in the labelling and package leaflet of medicinal products for human use) and their impacts on the products

bioMérieux | May 2017 - Sep 2017

Regulatory Affairs Trainee - Regulatory Compliance

Compliance upgrade of the In Vitro Medical Devices of the company, according to the IVDR EU 2017/746. I was a part of the implementation phase of the compliance project, including reviews of the Intended use and the Package leaflet for each product, planning and managing meetings with the implementation team, providing solutions for products that didn't fit the new regulation,etc. It was an enriching experience to work on a transversal project, with people with various profiles and from different horizons.

Shanghai Jiao Tong University | Oct 2016 - Dec 2016

Hospital Externship - Pharmacy Department

Hospital Internship performed at the Renji Hospital in Shanghai, with the collaboration of the Jiao Tong University. First part of this internship was made in the R&D unit of marine biologiy of the hospital. I was part of the project of discovering compounds of interest in sea sponges. The second part of the internship was about compliance of the patients, supervised by doctors and pharmacists.

Accord Healthcare | Jul 2016 - Sep 2016

Regulatory Affairs and Quality Assurance Trainee

During my internship I was in charge of various missions including: - AMM Transfert submissions - Price inquiring for drugs soon to be on the french market - Reviewing for confirmation release certificates - Checking Mock-ups - Dealing with Pharmacovigilance cases - Writing and reviewing of internal procedures and Business Continuity Plan of the company - Creating training tools about compliance with the "Chartes de la visite médicale" (medical sellers chart)

My Education

Take a look at my formal education

PharmD in Pharmacology, Regulatory Affairs of drug products and medical devicesFaculté des Sciences Pharmaceutiques et Biologiques de Lille | 2018

About Me

Thomas Bosio

Working in the pharmaceutical industry for years, I want now to help health companies and hospitals to make better decisions using data.

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