Safety Compliance Lead

Excelya; Boulogne-Billancourt; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Excelya recrute un Compliance Lead pour superviser l'équipe de pharmacovigilance à Boulogne-Billancourt. Vous serez responsable de la gestion des cas de sécurité, du respect des exigences réglementaires et du développement professionnel de votre équipe. Ce rôle clé exige une solide expérience en pharmacovigilance et des compétences en gestion, offrant une opportunité de croissance dans un environnement dynamique et innovant.

Qualifications

• Expérience significative en pharmacovigilance avec responsabilités managériales.
• Fortes connaissances réglementaires en pharmacovigilance, materiovigilance, nutrivigilance.
• Fluente en anglais (écrit et parlé).

Responsabilités

• Superviser une équipe multidisciplinaire et organiser les activités.
• Assurer le suivi continu de la sécurité des produits tout au long de leur cycle de vie.
• Gérer le processus complet de gestion des cas de sécurité : de la saisie au rapport.

Connaissances

Réglementation pharmacovigilance

Gestion de la sécurité des produits

Communication

Analyse de données

Gestion du stress

Formation

Expérience en pharmacovigilance

Compétences en leadership

Description du poste

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 is an exciting opportunity to contribute to a dynamic, ambitious team in Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Mains Responsibilities :

• Supervise a multidisciplinary team (product managers, safety officers, safety database administrator).
• Organize and monitor activities, allocate tasks, manage priorities, and support professional development.
• Ensure effective internal and external communication (management, EU QPPV, other departments).

Product Safety Monitoring

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

Safety Case Management

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

Cross-Functional Activities

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

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

• Experience : Huge 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).

Compliance Lead • Boulogne-Billancourt, Île-de-France, France