Rejoignez Excelya, où l'Audace, la Bienveillance et l'Énergie définissent qui nous sommes et notre manière de travailler. Nous croyons en la création de solutions audacieuses et en un environnement inclusif où la collaboration et le développement individuel vont de pair.

Vous souhaitez piloter des projets IT structurants dans un environnement international, transverse et exigeant, où votre capacité d’organisation, de communication et de pilotage fait réellement la différence ?
Rejoignez une équipe dynamique au cœur des systèmes et outils Global Safety.

Rejoignez Excelya, où Audace, Bienveillance et Énergie définissent qui nous sommes et notre façon de travailler.

Nous valorisons l'innovation, la collaboration et l'évolution continue dans un environnement stimulant et dynamique.

En tant que consultant(e) Assurance qualité, vous jouerez un rôle clé dans la gestion dela conformité réglementaire, du maintien du système qualité, et de la mise en œuvre des bonnes pratiques afin de garantir la sécurité, l’efficacité et la conformité des produits tout au long de leur cycle de vie.

Vos missions principales :

Au sein de l’équipe Qualité & Pharmacovigilance, vous prenez en charge la gestion complète des audits PV des filiales. À ce titre, vos responsabilités sont les suivantes :

• Réaliser les audits de Pharmacovigilance auprès des affiliés
• Rédiger les rapports d’audit PV de manière claire, rigoureuse et conforme aux exigences réglementaires
• Évaluer, valider et suivre les CAPA (Corrective and Preventive Actions) jusqu’à leur clôture
• Conduire les audits sur la base de questionnaires PV documentés, intégrant l’examen des preuves (fiches de poste, formations, procédures, etc.)

Requirements

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 Pharmacovigilance. 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.

Main responsibilities :

À propos du poste

Rejoignez Excelya, où Audace, Bienveillance et Énergie définissent qui nous sommes et notre façon de travailler. Nous valorisons l'innovation, la collaboration et l'évolution continue dans un environnement stimulant et dynamique.

En tant que Chargé(e) de Vigilance / Gestionnaire de Base de Données, vous jouerez un rôle clé dans la gestion des données de pharmacovigilance et assurerez un suivi rigoureux des informations de sécurité des produits.

Vos missions principales :

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 join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth

Mains Responsibilities :

The position involves performing as Local Contact Person responsible for Pharmacovigilance for Paris and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.

Work in several aspects of pharmacovigilance shall be expected, such as

Manage pharmacovigilance (PV) case processing, including receipt, acknowledgement, coding (MedDRA), seriousness assessment, and timely forwarding to the external PV provider.

Conduct follow‑up activities with reporters to obtain additional case information.

Handle increased PV case volumes during Early Access Programs (ATU/AAP).

Perform regular reconciliations with multiple stakeholders (PV vendor, MedInfo, QA, DSE, Business Partners, CRM, Market Research agencies, ATU/AAP provider, Global MedInfo).

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 join our dynamic and ambitious Regulatory Affairs team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth

The role is part-time and involves performing as Local Regulatory Affairs Expert providing consultancy services related to marketing authorizations and supporting regulatory activities for pharmaceutical products in Malta. Furthermore they must be able and willing to legally work as a Freelancer and be based and have experience working in Malta.

Work in several aspects of regulatory affairs shall be expected, such as:

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We are committed to fostering innovative partnerships that deliver value while transforming the clinical research landscape.

The Alliance Manager ensures that this transition happens smoothly, safely, and in line with regulatory obligations.

This role acts as a central project coordinator, working across PV, Regulatory, Legal, Supply Chain, and Business teams to secure the full transfer of safety responsibilities to the partner or acquiring company.

Main Responsibilities

1. Pharmacovigilance Transfer Coordination

• Coordinate end‑to‑end PV responsibility transfers when a product is sold or licensed to another company.
• Ensure safety data, regulatory obligations, and contractual PV commitments are clearly documented and handed over.
• Prepare and manage PV documentation required for buyers or partners.
• Support alignment between internal PV teams and external partners throughout the transition.

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.

Working in close collaboration with the Therapeutic Area Medical Lead, the Data Generation Strategy Lead, the Medical Data Center Statistician, Pharmacovigilance teams, and partners, the MEPS will manage assigned studies across one or more therapeutic areas, including Oncology, Hematology, Neuroscience, Immunology, and Ophthalmology.

The role requires strict adherence to applicable regulations, internal procedures, and compliance standards, ensuring high-quality study execution and data integrity.

Main Responsibilities:

About the Job

At Excelya, we embrace our core values of Audacity, Care, and Energy to shape the future of clinical research. As a Clinical Scientist in Immunology & Inflammation (I&I), you will collaborate closely with a talented multidisciplinary team to drive the success of our clinical trials.

This position provides an opportunity to engage in innovative research and contribute to studies aimed at addressing critical medical needs. You will be integral to ensuring the smooth execution of clinical trials while maintaining the highest scientific and ethical standards.

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.

You will be responsible for the medical assessment of sensitive pharmacovigilance files, often consisting of numerous medical documents. Expertise in neurology, obstetrics‑gynecology, or pediatrics is particularly valuable.

Your role will be to produce clear, accurate, and clinically rigorous medical summaries, supporting medico‑legal evaluations within the context of compensation requests.

Main Responsibilities: