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

CSL Behring

France
Not specified
Control of promotional documents
Amm dossier management
Pharmacovigilance system oversight
CSL Behring is seeking a Regulatory Affairs and Pharmacovigilance Manager to ensure compliance and quality standards at Seqirus France. The role involves document control, managing drug registration and pharmacovigilance processes, and requires a pharmacist with at least five years of relevant experience

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 product information, and overseeing the national pharmacovigilance system.
  • In the absence of the Responsible Pharmacist, the incumbent assumes full responsibility for quality systems, audits, and deviation handling.

Matching Summary

Match Score: 85

CSL Behring is seeking a Regulatory Affairs and Pharmacovigilance Manager to ensure compliance and quality standards at Seqirus France. The role involves document control, managing drug registration and pharmacovigilance processes, and requires a pharmacist with at least five years of relevant experience.

Skills & Requirements

Must-have

  • Control of promotional documents
  • AMM dossier management
  • Pharmacovigilance system oversight
  • ANSM regulatory compliance
  • Quality system management
  • Risk management plan implementation

Nice-to-have

  • LEA transparency regulation knowledge
  • Cross-border collaboration experience
  • Training and facilitation skills
  • Continuous improvement mindset
  • Stakeholder relationship management

Key Requirements

  • Doctorate in Pharmacy (Docteur en Pharmacie)
  • Minimum 5 years experience in Regulatory Affairs and Pharmacovigilance
  • Registration as an 'exploitant' with Section B of the Ordre des Pharmaciens
  • Master's degree or DU in Pharmaceutical Regulation/Pharmacovigilance

Work Rights

Must be registered with the French Order of Pharmacists

Tailored Resume

Cover Letter