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.
Candidates will manage the national pharmacovigilance system, including signal detection, risk management plans, and reporting to health authorities like ANSM.
The position requires acting as the primary contact for Transparency and Links regulations, overseeing external providers, and ensuring legal compliance with industry codes.
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
Risk management plan implementation
Quality assurance and audits
LEA transparency regulation compliance
Nice-to-have
Cross-border collaboration experience
Training and mentoring capabilities
Continuous improvement mindset
Strong stakeholder relationship management
Key Requirements
Doctorate in Pharmacy (Docteur en Pharmacie)
Minimum 5 years experience in Regulatory Affairs and Pharmacovigilance
Registration as an 'exploitant' at Section B of the Ordre des Pharmaciens
Master's degree or DU in pharmaceutical regulation/pharmacovigilance
Work Rights
Must be registered as an 'exploitant' at Section B of the Ordre des Pharmaciens