Description

Pharmacist specialised in Medical Devices with over 4 years of experience in regulatory affairs and quality. I am recognized for my reliability in post-market monitoring: complaints, CAPA, NC, risk management and audits.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Lille (up to 50km), Marseille (up to 50km), Lyon (up to 50km), Strasbourg (up to 50km), Nice (up to 50km)

TALAM - Food supplements
Freelance QARA
August 2024 - June 2025 (10 months)
QMS implementation Ensure GMP compliance Realize pharmacopoeia quality analysis Suppliers control Labeling activities Financiel Strategy Development of a fermentation process
Cristalens - Intraocular M.D.
Post Market Surveillance Coordinator
October 2022 - August 2024 (1 year and 10 months)
23 months - October 2022 to August 2024
Coordinator of PMS system: Quality, clinical and regulatory organisation Structuring the PMS activity from data collection to data analysis Drafting PMS procedure, plans, reports and PSUR for Intraocular lenses and calculator software Risk management support PMS compliance for international export registrations Design and conduct with the sales team of a surgeon survey
Cristalens - Intraocular M.D. Class IIB
Post Market Surveillance Coordinator
October 2022 - August 2024 (1 year and 10 months)
23 months - October 2022 to August 2024
Coordinator of PMS system: Quality, clinical and R&D departments organisation.
Structuring the PMS activity from claims, CAPA, NC collection to analysis.
Ensure GMP compliance: quality control, process validation, product stability, storage.
Drafting PMS procedure, plans, reports and PSUR for Intraocular lenses and calculator software.
Risk management support
PMS compliance for international export registrations
Design and conduct with the sales team of a surgeon survey

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Doctor of Pharmacy
Institute of Pharmacological and Biological Sciences
2021
Doctor of Pharmacy - Pharm D
Biomedical Engineer
Polytech Lyon Engineering School
Biomedical Engineer

Check out Jean-Nicolas's education

Other

Jean-Nicolas Pagano

Affaires réglementaires et qualité - DM

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