Responsable Affaires Réglementaires Et Pharmacovigilance (rpv/lso) - Pharmacien Responsable Intérimaire
CSL Ltd
Paris, France
On-site
Control of promotional documents
Submission to health authorities
Management of maa files
The role involves ensuring regulatory compliance and quality of laboratory activities, including the control of promotional materials and the management of marketing authorization files
Job Summary
The role involves ensuring regulatory compliance and quality of laboratory activities, including the control of promotional materials and the management of marketing authorization files.
Key responsibilities include implementing and managing the pharmacovigilance system, handling adverse event reporting, and ensuring compliance with risk management plans.
The position also requires adherence to company policies, contributing to the definition of transparency policies, and advising on projects involving healthcare professionals.
Matching Summary
The role involves ensuring regulatory compliance and quality of laboratory activities, including the control of promotional materials and the management of marketing authorization files.
Skills & Requirements
Must-have
control of promotional documents
submission to Health Authorities
management of MAA files
pharmacovigilance system management
adverse event reporting
risk management system implementation
compliance with LEA/Transparency regulations
Nice-to-have
continuous improvement of PV system
collaboration with cross-functional teams
participation in working groups
Key Requirements
Doctorate in Pharmacy
Master's in pharmaceutical regulation or pharmacovigilance diploma
Minimum 5 years of experience in Regulatory Affairs and Pharmacovigilance
Eligible for registration with the French Pharmacist Order (Section B)