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

Seqirus France

France
Not specified
5 years experience in regulatory affairs
Expertise in pharmacovigilance systems
Knowledge of ansm regulations
Seqirus France is seeking a Regulatory Affairs and Pharmacovigilance Manager to ensure regulatory compliance and quality within the pharmaceutical lab. The ideal candidate will have a Doctorate in Pharmacy, significant experience in regulatory affairs, and a strong understanding of pharmacovigilance practices

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 promotional materials, and overseeing the national pharmacovigilance system.
  • In the absence of the Responsible Pharmacist, the incumbent manages quality systems, audits, and corrective actions to ensure operational continuity.

Matching Summary

Match Score: 85

Seqirus France is seeking a Regulatory Affairs and Pharmacovigilance Manager to ensure regulatory compliance and quality within the pharmaceutical lab. The ideal candidate will have a Doctorate in Pharmacy, significant experience in regulatory affairs, and a strong understanding of pharmacovigilance practices.

Skills & Requirements

Must-have

  • 5 years experience in Regulatory Affairs
  • Expertise in pharmacovigilance systems
  • Knowledge of ANSM regulations
  • Control of promotional documents
  • AMM dossier management
  • Quality system oversight

Nice-to-have

  • Experience with LEA transparency laws
  • Leadership training capabilities
  • Cross-border project coordination
  • Fluency in French regulatory context

Key Requirements

  • Doctorate in Pharmacy (Docteur en Pharmacie)
  • Registration as an 'exploitant' at Section B of the Ordre des Pharmaciens
  • Minimum 5 years of relevant professional experience
  • Master's degree or DU in pharmaceutical regulation/pharmacovigilance

Work Rights

Must be registered with the French Order of Pharmacists

Tailored Resume

Cover Letter