Carine Maury Laribière

Pharmacist with 7 years of experience working for pharmaceutical marketing authorization holders, covering Regulatory Affairs, Pharmacovigilance and Quality Assurance in both French and international environments.

Salaire / Taux journalier

Saint-Malo, France

Freelance, ouvert au CDI

Peut venir sur site

Expertises

Test & QAConformité réglementaireFormation

Langues

Français (Maternelle)Anglais (Courant)

À propos

Introduction

Pharmacist with 7 years of experience working for pharmaceutical marketing authorization holders, covering Regulatory Affairs, Pharmacovigilance and Quality Assurance in both French and international environments.

Liens

Expérience de travail

Pharmacist officer

DB PHARMA

nov. 2019 - Présent

7 ans

Vétheuil, France

Pharmacist with a transversal role covering Regulatory Affairs, Pharmacovigilance and Quality Assurance. Accountable for regulatory compliance of marketed medicinal products, oversight of the pharmacovigilance and quality systems, and interfaces with health authorities, partners and internal teams in a French and international context. Regulatory Affairs Maintenance of Marketing Authorizations (MA) and management of variations (France and export: Asia, Africa, Middle East) Regulatory intelligence and impact analysis (ANSM, EMA, ICH) Review and approval of regulatory dossiers and packaging materials Pharmacovigilance – Deputy QPPV / EU QPPV Oversight of the pharmacovigilance system (PSMF, PSURs, signal detection) Management and supervision of pharmacovigilance cases (L2A, MLM) Coordination with partners (distributors, service providers), PV audits Training of teams and management of medical information Quality Assurance Supervision and continuous improvement of the Quality Management System (procedures, PQR, CAPA, change control) Management of complaints and batch recalls Preparation for and participation in audits and inspections Qualification and monitoring of manufacturers and partners

Consultant

ATESSIA , Life Science Advisors

avr. 2018 - déc. 2019

1 an 9 mois

Région de Paris, France

Deputy Pharmacist at CSL Behring: management of complaints, product returns, and administrative batch release Consultant Pharmacist: drafting of procedures, submission of administrative variations, support for pharmaceutical establishment opening, PSUR writing

Regulatory affairs trainee

Actelion

sept. 2017 - déc. 2019

2 ans 4 mois

7620 Paris, Danemark

Quality: management and follow‑up of packaging materials (pregnancy pictograms), controlled distribution for ATU, calculation of quality indicators Pharmacovigilance: case processing, translation, causality assessment, registry follow‑up, literature monitoring Participation in compliance with the French Sunshine Act (DMOS) and transparency requirements Participation in implementation of compliance with promotional information charte

Project manager

pharmacieplus société coopérative & holding

mai 2012 - juil. 2016

4 ans 3 mois

1121 Bremblens, Suisse

Responsible for the "good advice" project for Pharmacy plus (French-speaking network of 91 pharmacies): improve sales through training and IT support.

Editor and project manager of French-speaking Switzerland

pnn pharma nation network ag

mai 2008 - oct. 2012

4 ans 6 mois

Zurich, Suisse

Design and development of pharmaceutical indication modules for pharmacy staff, physicians

Pharmacien remplacant

Hôpital Saint Hilaire du Harcoët - hôpital de Mortain

janv. 2003 - déc. 2006

4 ans

Saint Hilaire du Harcöet - Mortain

gestion de la pharmacie de l'hôpital, management de l'équipe de 5 préparateurs, interface médecins et administration

Intervenante en pharmacologie

Ecoles d'infirmières

sept. 1999 - juil. 2006

6 ans 11 mois

Rueil Malmaison, Levallois Perret, Dinan

Conception de cours des grandes classes de médicaments et de la surveillance infirmière

Rédactrice- formatrice

CIEFA - page officielle

févr. 2005 - oct. 2005

9 mois

7620 Paris, Danemark

Réalisation du programme de certification vente et promotion de produits pharmaceutiques en officine

Pharmacien assistant

Pharmacies

janv. 1994 - déc. 2000

7 ans

92500 Rueil-Malmaison, France

Remplacement du titulaire, assistanat, administration, délivrance médicaments

Faisant fonction d'interne

Hôpital Trousseau Paris

sept. 1993 - août 1994

1 an

7620 Paris, Danemark

Laboratoire de biochimie, analyse, dosage, ionogramme, service de garde, attachée au service pédiatrique de gastroentérologie


Formation

PHARMACOVIGILANCE

Formation DIA: Electronic reporting of ICSRs knowledge, EV TRAINING: Extended Eudravigilance Medicinal Product Dictionary knowledge

2018 - Présent

8 ans 10 mois

Université Paris-Saclay

Master de sciences, technologies, santé, mention sciences du médicament, Affaires réglementaires des industries de santé

2016 - 2018

1 an 11 mois

Université PARIS V

Diplôme d'état de docteur en pharmacie, Pharmacy

Résultat : très honorable


Licences et certifications

PHARMACOVIGILANCE Training

Délivré le : janv. 2018

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