Responsable Affaires Réglementaires Et Pharmacovigilance (rpv/lso) - Pharmacien Responsable Intérimaire
Seqirus France
France
Control of promotional documents
Amm dossier management
Pharmacovigilance system oversight
The role involves ensuring regulatory compliance and quality for Seqirus France products under the direction of the Responsible Pharmacist
Job Summary
The role involves ensuring regulatory compliance and quality for Seqirus France products under the direction of the Responsible Pharmacist.
Key responsibilities include managing marketing authorization dossiers, validating product information, and overseeing the national pharmacovigilance system.
In the absence of the Responsible Pharmacist, the incumbent manages quality systems, handles deviations, and prepares for health authority inspections.
Matching Summary
The role involves ensuring regulatory compliance and quality for Seqirus France products under the direction of the Responsible Pharmacist.
Skills & Requirements
Must-have
Control of promotional documents
AMM dossier management
Pharmacovigilance system oversight
ANSM regulatory compliance
Quality system management
Risk management plan implementation
Nice-to-have
LEA transparency regulation knowledge
Cross-border collaboration experience
Training session facilitation skills
Electronic document management expertise
Key Requirements
Doctorate in Pharmacy (Docteur en Pharmacie)
Minimum 5 years experience in Regulatory Affairs and Pharmacovigilance
Registration as 'exploitant' with Section B of the Ordre des Pharmaciens
Master's degree or DU in Pharmaceutical Regulation/Pharmacovigilance
Work Rights
Must be registered with the French Order of Pharmacists