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

Seqirus France

France
Control of promotional documents
Amm dossier management
Pharmacovigilance system oversight
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 ANSM.
  • The position requires acting as the interim Responsible Pharmacist in their absence, overseeing quality systems, audits, and product quarantines.

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

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

Nice-to-have

  • LEA transparency regulation knowledge
  • Cross-border project experience
  • Training session facilitation skills
  • Electronic document management expertise

Key Requirements

  • Doctorate in Pharmacy (Docteur en Pharmacie)
  • Minimum 5 years experience in Regulatory Affairs and Pharmacovigilance
  • Registration 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