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

Seqirus

France
5 years experience in regulatory affairs
5 years experience in pharmacovigilance
Control of promotional documents
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.
  • In the absence of the Responsible Pharmacist, the incumbent assumes full responsibility for quality systems, audits, and product release.

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

  • 5 years experience in Regulatory Affairs
  • 5 years experience in Pharmacovigilance
  • Control of promotional documents
  • AMM dossier management
  • Quality system oversight
  • Signal detection and risk management

Nice-to-have

  • Knowledge of LEA and Transparency laws
  • Experience with GVP Module IX
  • Training and mentoring capabilities
  • Cross-border project coordination

Key Requirements

  • Doctorate in Pharmacy (Docteur en Pharmacie)
  • Registration as '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 inscribable as 'exploitant' at Section B of the Ordre des Pharmaciens

Tailored Resume

Cover Letter