Responsable Affaires Réglementaires Et Pharmacovigilance (rpv/lso) - Pharmacien Responsable Intérimaire
CSL Limited
Paris, France
On-site
Regulatory document control
Marketing authorization dossiers
Pharmacovigilance system management
The role involves ensuring regulatory compliance and quality for Seqirus France's activities, including control of promotional and non-promotional documents
Job Summary
The role involves ensuring regulatory compliance and quality for Seqirus France's activities, including control of promotional and non-promotional documents.
Key responsibilities include managing marketing authorization dossiers, legal mentions, and participating in regulatory operations and vigilance.
The position also requires managing the pharmacovigilance system, handling adverse event reporting, and ensuring compliance with transparency regulations regarding healthcare professionals.
Matching Summary
The role involves ensuring regulatory compliance and quality for Seqirus France's activities, including control of promotional and non-promotional documents.
Skills & Requirements
Must-have
Regulatory document control
Marketing authorization dossiers
Pharmacovigilance system management
Adverse event reporting
Risk management system implementation
Transparency and link declaration
Nice-to-have
Continuous improvement of PV system
Cross-functional project participation
Training delivery on regulatory topics
Key Requirements
Doctor of Pharmacy degree
Master's in pharmaceutical regulation or pharmacovigilance diploma
Minimum 5 years of experience in Regulatory Affairs and Pharmacovigilance
Registered with the French Pharmacist Order (Section B)