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. In this pivotal role, you will report directly to the Director of Pharmaceutical Affairs and be instrumental in ensuring regulatory compliance and quality within our laboratory operations.

Key Responsibilities

• Regulatory Affairs:
  • Review promotional and non-promotional documents for compliance.
  • Prepare and facilitate 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 Dossiers:
  • Submit and track marketing authorization applications and variations.
  • Draft legal mentions for products and participate in packaging approvals.
  • Validate product information updates and anticipate necessary actions.
• Quality Management:
  • Manage quality systems and follow up on product batches.
  • Address product quality complaints and deviations.
  • Prepare for internal and external audits.
• Pharmacovigilance:
  • Implement and manage the pharmacovigilance system nationally.
  • Ensure compliance with adverse event reporting and risk management.
  • Participate in signal detection and validation processes.
• Training and Compliance:
  • Conduct training sessions on regulatory activities.
  • Stay updated on regulatory changes and scientific knowledge.

Requirements

• Education:
  • Doctorate in Pharmacy.
  • Master's in Pharmaceutical Regulation or a Diploma in Pharmacovigilance.
• Experience:
  • Minimum of 5 years in Regulatory Affairs and Pharmacovigilance.
  • Eligibility for registration as an "exploiter" in the Pharmacy 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 regulations is a plus.

Working Conditions

This position offers a collaborative work environment with opportunities for professional development. You will be part of a team that values innovation and compliance.

Benefits

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

Opportunities for Growth

Join us to enhance your career in a supportive environment that encourages professional development and values your contributions. You will have the chance to work on diverse projects and collaborate with cross-functional teams.

If you are passionate about regulatory affairs and pharmacovigilance and want to make a difference in the pharmaceutical industry, we would love to hear from you!