Responsable Réglementaire et Pharmacovigilance - Pharmacien Intérimaire

Join Our Team as a Regulatory Affairs and Pharmacovigilance Professional

We are seeking a dedicated Regulatory Affairs and Pharmacovigilance Professional to join our dynamic team. Reporting to the Director of Pharmaceutical Affairs, you will play a crucial role in ensuring regulatory compliance and maintaining the quality of our laboratory activities.

Key Responsibilities

• Regulatory Affairs:
  • Review promotional and non-promotional documents for compliance.
  • Prepare and lead cross-functional MMR (Medical Marketing Regulatory) meetings.
  • Ensure timely submission of all visa requests to Health Authorities.
  • Validate positive lists before the Pharmacist's signature.
  • Coordinate with sales, marketing, medical, and economic affairs departments.
• Marketing Authorization Files:
  • Submit and track marketing authorization applications and variations.
  • Draft legal mentions for our products.
  • Participate in the approval of packaging articles.
  • Validate VIDAL monographs and update product information.
• Pharmacovigilance:
  • Establish and manage the pharmacovigilance system nationally.
  • Ensure compliance with pharmacovigilance obligations, including adverse event reporting.
  • Monitor and respond to requests from health authorities.
• Quality Management:
  • Oversee quality system management in the absence of the Pharmacist.
  • Handle product quality complaints and deviations.
  • Prepare for internal and external audits.

Requirements

• Education:
  • Doctorate in Pharmacy or a Master's in Pharmaceutical Regulation.
• Professional Experience:
  • Minimum of 5 years of successful experience in Regulatory Affairs and Pharmacovigilance.
  • Registered as an "exploiter" in Section B (Industry) of the Pharmacists' Order.
• Specific Knowledge:
  • Strong understanding of advertising regulations and marketing authorization processes.
  • Familiarity with Good Manufacturing Practices and Good Distribution Practices.
  • Knowledge of LEA and Transparency laws is a plus.

Working Conditions

This position offers a collaborative work environment with opportunities to engage in various projects and initiatives within the organization. You will be part of a team that values compliance and quality in all aspects of pharmaceutical operations.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health and wellness programs.
• Opportunities for professional development and career advancement.

Opportunities for Growth

We are committed to fostering a culture of continuous improvement and professional development. You will have access to training programs and resources to enhance your skills and advance your career within the organization.

If you are passionate about regulatory affairs and pharmacovigilance and want to make a difference in the pharmaceutical industry, we encourage you to apply!