Safety Compliance Lead

JR France; Paris; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Une entreprise de santé dynamique recherche un responsable en pharmacovigilance pour superviser une équipe et assurer la sécurité des produits. Ce rôle implique la gestion des cas de sécurité, la rédaction de documents et la conformité réglementaire. Rejoignez une équipe qui valorise l'audace et le développement personnel dans un environnement stimulant.

Qualifications

• Expérience en pharmacovigilance avec des responsabilités managériales.
• Compétences en gestion de l'équipe et en communication.
• Capacité à gérer des données et à respecter les délais.

Responsabilités

• Superviser une équipe pluridisciplinaire et gérer les priorités.
• Assurer le suivi de la sécurité des produits tout au long de leur cycle de vie.
• Gérer le processus complet de gestion des cas de sécurité.

Connaissances

Connaissance des exigences réglementaires

Gestion des bases de données de sécurité

Rédaction de rapports

Gestion des signaux

Formation

Expérience extensive en pharmacovigilance

Description du poste

Social network you want to login/join with:

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to contribute to a dynamic, ambitious Safety team. You will play a key role in driving innovation and making an impact in clinical research, while working in a stimulating environment that encourages personal and professional growth.

Main Responsibilities:

1. Supervise a multidisciplinary team (product managers, safety officers, safety database administrator).
2. Organize and monitor activities, allocate tasks, manage priorities, and support professional development.
3. Ensure effective communication within the team and with external stakeholders (management, EU QPPV, other departments).

Product Safety Monitoring

1. Ensure continuous monitoring of product safety and appropriate use throughout the product lifecycle.
2. Oversee drafting safety documents (PSUR, RMP, ACO) and signal management.
3. Implement and follow up on risk management plans.

Safety Case Management

1. Oversee the full case management process: from intake to reporting, including analysis and quality control.
2. Manage the safety database: maintenance, data integration, extraction, and reconciliation activities.

Cross-Functional Activities

1. Participate in regulatory intelligence, document management, audits, and inspections.
2. Monitor performance indicators and propose continuous improvement actions.
3. Ensure regulatory compliance and team training.

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals ready to grow with us and share our values.

• Experience: Extensive experience in pharmacovigilance, including managerial responsibilities.
• Skills: Strong knowledge of regulatory requirements (pharmacovigilance, materiovigilance, nutrivigilance), safety databases, report writing, and signal management.
• Education: Excellent leadership, communication, data analysis, and stress management skills.
• Languages: Fluent in English (spoken and written).