Responsable Affaires Réglementaires Et Pharmacovigilance (rpv/lso) - Pharmacien Responsable Intérimaire

Seqirus France

France
**
Regulatory compliance for pharmaceutical products
Pharmacovigilance system management
Control of promotional documents
** Seqirus France is seeking a Regulatory Affairs and Pharmacovigilance Manager for a temporary role, responsible for ensuring regulatory compliance and overseeing pharmacovigilance activities. The ideal candidate will have a doctorate in pharmacy, significant experience in regulatory affairs, and specific knowledge in pharmacovigilance. **

Job Summary

  • The role involves managing regulatory compliance and pharmacovigilance activities for Seqirus France under the supervision of the Responsible Pharmacist.
  • Candidates will be responsible for validating promotional materials, submitting marketing authorization dossiers, and overseeing the national pharmacovigilance system.
  • In the absence of the Responsible Pharmacist, the incumbent assumes full responsibility for quality systems, batch release, and handling regulatory inspections.

Matching Summary

Match Score: 75

** Seqirus France is seeking a Regulatory Affairs and Pharmacovigilance Manager for a temporary role, responsible for ensuring regulatory compliance and overseeing pharmacovigilance activities. The ideal candidate will have a doctorate in pharmacy, significant experience in regulatory affairs, and specific knowledge in pharmacovigilance. **

Skills & Requirements

Must-have

  • Regulatory compliance for pharmaceutical products
  • Pharmacovigilance system management
  • Control of promotional documents
  • AMM dossier submission and tracking
  • Quality assurance and audit preparation
  • Risk management plan implementation

Nice-to-have

  • Experience with LEA transparency regulations
  • Knowledge of ANSM specific requirements
  • Cross-border collaboration skills
  • Training and mentoring capabilities

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

Tailored Resume

Cover Letter