Responsable Affaires Réglementaires Et Pharmacovigilance (rpv/lso) - Pharmacien Responsable Intérimaire
Seqirus France
France
5 years experience in regulatory affairs
Pharmacovigilance system management
Control of promotional documents
The role involves managing regulatory compliance and pharmacovigilance activities for Seqirus France under the direction of the Responsible Pharmacist
Job Summary
The role involves managing regulatory compliance and pharmacovigilance activities for Seqirus France under the direction of the Responsible Pharmacist.
Candidates will be responsible for controlling promotional documents, submitting marketing authorization dossiers, and ensuring adherence to ANSM regulations.
In the absence of the Responsible Pharmacist, the incumbent assumes full responsibility for quality systems, batch release, and handling deviations.
Matching Summary
The role involves managing regulatory compliance and pharmacovigilance activities for Seqirus France under the direction of the Responsible Pharmacist.
Skills & Requirements
Must-have
5 years experience in Regulatory Affairs
Pharmacovigilance system management
Control of promotional documents
AMM dossier submission and tracking
Quality system and audit participation
LEA and transparency regulation compliance
Nice-to-have
Knowledge of French advertising laws
Experience with CSL global operations
Cross-border regulatory coordination
Training and mentoring capabilities
Key Requirements
Doctorate in Pharmacy (Docteur en Pharmacie)
Minimum 5 years experience in Regulatory Affairs and Pharmacovigilance
Registration as 'exploitant' Section B at Ordre des Pharmaciens
Master's degree or DU in Pharmaceutical Regulation/Pharmacovigilance
Work Rights
Must be registered as 'exploitant' Section B at Ordre des Pharmaciens