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

Century Center

5+ years regulatory affairs experience
Pharmacovigilance system management
French regulatory compliance expertise
The role involves managing regulatory compliance, promotional document control, and pharmacovigilance activities for Seqirus France

Job Summary

  • The role involves managing regulatory compliance, promotional document control, and pharmacovigilance activities for Seqirus France.
  • Candidates will act as the interim Responsible Pharmacist in the absence of the primary holder, overseeing quality systems and audits.
  • The position requires ensuring adherence to French health authority regulations including ANSM requirements for safety reporting and risk management.

Matching Summary

The role involves managing regulatory compliance, promotional document control, and pharmacovigilance activities for Seqirus France.

Skills & Requirements

Must-have

  • 5+ years Regulatory Affairs experience
  • Pharmacovigilance system management
  • French regulatory compliance expertise
  • Promotional document control
  • AMM dossier submission and tracking

Nice-to-have

  • Knowledge of LEA transparency laws
  • Experience with CSL global operations
  • Training and facilitation skills
  • Electronic Document Management systems

Key Requirements

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

Work Rights

Must be registered with the French Order of Pharmacists (Section B)

Tailored Resume

Cover Letter