Responsable Affaires Réglementaires Et Pharmacovigilance (rpv/lso) - Pharmacien Responsable Intérimaire
CSL Behring
France
5 years experience in regulatory affairs
Pharmacovigilance system management
French regulatory compliance knowledge
The role involves managing regulatory affairs and pharmacovigilance activities to ensure full compliance with French health authority regulations
Job Summary
The role involves managing regulatory affairs and pharmacovigilance activities to ensure full compliance with French health authority regulations.
Candidates will oversee the submission of marketing authorization dossiers, validate promotional materials, and manage risk management plans at the national level.
In the absence of the Responsible Pharmacist, the incumbent assumes critical quality system responsibilities including audit preparation and deviation handling.
Matching Summary
The role involves managing regulatory affairs and pharmacovigilance activities to ensure full compliance with French health authority regulations.
Skills & Requirements
Must-have
5 years experience in Regulatory Affairs
Pharmacovigilance system management
French regulatory compliance knowledge
AMM dossier submission expertise
Promotional document control skills
Nice-to-have
Knowledge of LEA and Transparency laws
Experience with GVP Module IX
Cross-border project coordination
Training and facilitation skills
Electronic Document Management systems
Key Requirements
Doctorate in Pharmacy (Docteur en Pharmacie)
Registration as 'exploitant' with Section B of Ordre des Pharmaciens
Minimum 5 years of relevant professional experience
Master's degree or DU in Pharmaceutical Regulation/Pharmacovigilance
Work Rights
Must be inscribable to the Ordre des Pharmaciens (Section B)