Anne-Sophie GANDUBERT
PV and Pharmaceutical Affairs Freelance
Salaire / Taux journalier
Paris, France
Freelance
Expertises
Langues
Expérience de travail
Freelance Pharmacovigilance - Pharmaceutical Affairs
FreelanceFreelance
juil. 2025 - Présent
1 an 4 mois
Chugai Pharma France
août 2014 - Présent
12 ans 3 mois
92800 Puteaux, France
Pharmaceutical Affairs Director - Chief Pharmaceutical Officer - Local QPPV / MI - EU QPPV Deputy
janv. 2022 - Présent
4 ans 10 mois
92800 Puteaux, France
Member of the Executive Committee and Management of the Regulatory Affairs / Pharmacovigilance and Medical Information / Quality Assurance team (5) Relocation of an "Exploitant" Operator site Merger of two "Exploitant" sites including merger of the 2 QMS ANSM Pharmacovigilance Inspection (1) ANSM Exploitant Inspection (1) Certification audits of Promotional Information (3) Co-promotion with Roche
Local QPPV / MI - Chief Pharmaceutical Officer Deputy - EU QPPV Deputy
juil. 2017 - déc. 2021
4 ans 6 mois
92800 Puteaux, France
- Pharmacovigilance activities in France, Belgium and Luxembourg (service provider management), ANSM PV inspection (1) - EU QPPV Deputy role in interaction with the European team and the headquarter in Japan - Medical Information activities in France, Belgium and Luxembourg - Chief Pharmaceutical Officer Deputy
Local QPPV / MI - EU QPPV Deputy
janv. 2016 - juil. 2017
1 an 7 mois
92800 Puteaux, France
- Pharmacovigilance activities in France, Belgium and Luxembourg (service provider management), - EU QPPV Deputy role in interaction with the European team and the headquarter in Japan - Medical Information activities in France, Belgium and Luxembourg - Chief Pharmaceutical Officer Deputy training
Local QPPV / MI
août 2014 - déc. 2015
1 an 5 mois
- Pharmacovigilance activities in France, Belgium and Luxembourg (service provider management), - Medical Information activities in France, Belgium and Luxembourg - EU QPPV Deputy training
Local QPPV
Vifor Pharma
mars 2011 - juil. 2014
3 ans 5 mois
- Activities Vifor France "Exploitant": Inhousing PV activities : termination of the PV service provision and set up of inhouse PV department PV activities management of the French affiliate - Activities Vifor France MA Holder for Europe: Preparation and participation in 2 MHRA PV inspections, participation in internal Drug Safety Boards, Monthly meetings with the EU QPPV and the Head of Global Drug Safety.
Pharmacist PV Expert
Pfizer
juil. 2003 - mars 2011
7 ans 9 mois
Paris, France
In addition to Product/Quality Assurance/Transversal activities: - Implementation of a new Risk Management Plan - Preparation and participation in National Pharmacovigilance Commissions (Afssaps) as part of a national Pharmacovigilance follow-up - Management of a national Pharmacovigilance follow-up and follow-up of a Risk Management Plan - Preparation of ANSM PV Inspection - Replacement for PV Director; in 2008, assignment as PV Director (Pharmacovigilance Referent for Pfizer Santé Grand Public and for Regulatory Affairs) Product Activities : - Management of spontaneous and clinical trials cases for products in the Cardiovascular, CNS, OTC and Ophthalmology TA, assessment and reporting to Afssaps - Management of French ASRs, PSURs and syntheses: preparation and distribution of the annual PSUR calendar to Afssaps, submission of PSURs, ASRs and French syntheses Quality assurance activities: - Preparation and follow-up of internal audits, inspection readiness, preparation of the Local Document describing the activities of Pfizer's Pharmacovigilance Department in France - Drafting of local procedures - Validation of the Pharmacovigilance clause in contracts with various service providers and partners - Drafting and validation of pharmacovigilance agreements Transversal activities: - Validation of SmPC/leaflet sections concerning product safety - Evaluation of clinical documents (protocol, consent, etc.) and participation in the Clinical Document Evaluation Committee - Training Pfizer personnel in Pharmacovigilance obligations - Participation in the on-call rota system - Recruitment and supervision of trainees
PV trainee then PV officer
Bayer
sept. 2001 - juil. 2003
1 an 11 mois
92800 Puteaux, France
Management of spontaneous and clinical trials adverse events PSURs and french syntheses writing
Formation
Université de Rennes I
Docteur en pharmacie
Licences et certifications
DU Auditeur qualité dans l'industrie du médicament
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