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

CSL Limited

France
**
5 years experience in regulatory affairs
Pharmacovigilance system management
Control of promotional documents
** CSL Limited is seeking a Regulatory Affairs and Pharmacovigilance professional to join Seqirus France as an interim Responsible Pharmacist. The role involves ensuring regulatory compliance, managing pharmacovigilance activities, and collaborating with various departments to maintain product quality and safety. **

Job Summary

  • The role involves managing regulatory compliance and quality activities for Seqirus France under the direction of the Responsible Pharmacist.
  • Key responsibilities include overseeing pharmacovigilance systems, managing AMM dossiers, and ensuring adherence to French health authority regulations.
  • In the absence of the Responsible Pharmacist, the incumbent assumes full responsibility for quality management, including audits, CAPAs, and product release.

Matching Summary

Match Score: 75

** CSL Limited is seeking a Regulatory Affairs and Pharmacovigilance professional to join Seqirus France as an interim Responsible Pharmacist. The role involves ensuring regulatory compliance, managing pharmacovigilance activities, and collaborating with various departments to maintain product quality and safety. **

Skills & Requirements

Must-have

  • 5 years experience in Regulatory Affairs
  • Pharmacovigilance system management
  • Control of promotional documents
  • AMM dossier submission and follow-up
  • Quality system oversight and audits
  • LEA and Transparency regulation compliance

Nice-to-have

  • Knowledge of GVP Module IX guidelines
  • Experience with electronic document management systems
  • Ability to train cross-functional teams
  • Strong stakeholder management skills
  • Fluency in French regulatory landscape

Key Requirements

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

Tailored Resume

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