Services for ICSR Quality and Compliance

Excelya; Paris; Sur place; EUR 45 000 - 70 000; Plein temps

Résumé du poste

Une entreprise de santé dynamique à Paris recherche un spécialiste en pharmacovigilance pour rejoindre son équipe ambitieuse. Le candidat idéal contribuera à la stratégie réglementaire et interagira avec les autorités de santé, tout en travaillant dans un environnement stimulant qui favorise l'innovation et la croissance personnelle. Un Master en conformité est requis, ainsi qu'une maîtrise du français et de l'anglais.

Qualifications

• Capacité prouvée à travailler dans des environnements collaboratifs et dynamiques.
• Compréhension solide des exigences réglementaires et procédures de soumission.
• Maîtrise du français et de l'anglais.

Responsabilités

• Développer et mettre en œuvre la stratégie réglementaire régionale liée à la pharmacovigilance.
• Agir en tant que liaison principale avec les équipes de réglementation locale et de pharmacovigilance.
• Maintenir et mettre à jour les bases de données réglementaires liées à la sécurité.

Connaissances

Compréhension des procédures d'enregistrement

Interactions avec les autorités de santé

Formation

Master en conformité ou domaine connexe

Description du poste

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Services for ICSR Quality and Compliance, Paris

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Client:

Excelya

Location:

Paris, France

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

168d04cc6d54

Job Views:

3

Posted:

23.07.2025

Expiry Date:

06.09.2025

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Job Description:

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.

• Develop and implement the regional regulatory strategy related to pharmacovigilance and drug safety.
• Oversee regulatory submissions and registrations with a focus on safety-related documentation and compliance.
• Act as the primary liaison with Local Regulatory Affairs (LRA) and Pharmacovigilance teams to ensure alignment on safety regulations.
• Consolidate and interpret regional safety requirements; advise the Global Regulatory Leader (GRL) on national safety regulations and changes.
• Support preparation and review of regulatory dossiers with an emphasis on safety data and risk management plans.
• Assist in drafting responses to Health Authorities’ questions concerning safety issues and provide detailed clarifications on regulatory queries.
• Maintain and update safety-related regulatory databases and documentation.
• Ensure Life Cycle Management (LCM) activities include safety-related variations and compliance updates.

Requirements

About You

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: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—talent matters most to us!)
• Skills: Solid understanding of registration file preparation, submission procedures, and Health Authority interactions.
• Education: Minimum Master’s degree (Bac +5) in compliance or a related field
• Languages: Fluency in French & English

Why Join Us?

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.