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.

We are looking for a Senior Oracle Argus Safety Consultant to play a key role in maintaining, optimizing, and shaping the future of a global pharmacovigilance platform, while acting as a trusted partner to business, compliance, and technical stakeholders.

Key responsibilities :

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

Key responsabilities:

• Perform the medical review and assessment of sensitive and complex pharmacovigilance cases based on source documents and medical records.
• Analyze case documentation to identify, extract and evaluate relevant medical information in accordance with applicable procedures and guidelines.
• Contribute to the medical and scientific evaluation of safety cases, ensuring the completeness, consistency and accuracy of collected data.
• Collaborate closely with Pharmacovigilance Operations teams to support case processing activities.
• Review documentation to identify potential duplicate cases and support their assessment in collaboration with PV teams.
• Identify potential adverse events and ensure their timely communication for entry into the global pharmacovigilance database.
• Assess and communicate significant new safety information and follow-up data arising from additional source documentation.
• Ensure compliance with pharmacovigilance regulations, internal procedures and quality standards.
• Support continuous improvement initiatives related to medical case review and pharmacovigilance processes.

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

The successful candidate will play a key role in driving innovation, optimizing pharmacovigilance processes and improving data governance following the implementation of a new safety database platform. This position requires a strong combination of pharmacovigilance subject matter expertise, project leadership and a consulting mindset, with the ability to bridge business operations, digital technology teams and external solution providers.

Key Responsibilities

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.

In this role, you will combine operational PV expertise with project coordination responsibilities to ensure patient safety and regulatory compliance throughout the product lifecycle.

Main Responsibilities:

• Manage and oversee pharmacovigilance case processing activities from receipt to reporting.
• Collect, assess, document, and follow up on adverse event reports from multiple sources.
• Perform quality review and medical consistency checks of safety cases prior to submission.
• Support local signal detection activities and contribute to safety monitoring initiatives.
• Participate in literature surveillance and regulatory intelligence activities.
• Contribute to periodic safety reports and monthly PV activity reporting.
• Collaborate with Global Safety, Medical Information, Clinical Teams, and external partners.
• Maintain complete and inspection-ready PV documentation, tracking, and archiving.
• Support the review and continuous improvement of local PV procedures and processes.
• Act as a key PV contact, ensuring clear communication, escalation, and stakeholder management.

Requirements

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 and ambitious team. 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

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 and ambitious team. 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

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 and ambitious team. 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

Rejoignez Excelya, où l'audace, l'attention portée aux autres et l'énergie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Ce poste représente une opportunité stimulante de rejoindre une équipe dynamique et ambitieuse. Vous jouerez un rôle clé dans le support qualité des activités de Pharmacovigilance Quality (PV Quality), en contribuant à la maîtrise des risques identifiés et au renforcement de la conformité globale.

Vos missions principales

Dans le cadre du développement de notre agence lyonnaise, Excelya recherche de nouveaux talents passionnés pour accompagner sa croissance et contribuer à des projets innovants dans le secteur de la recherche clinique.

Vos missions

Au sein de l'équipe Pharmacovigilance, vous participerez notamment à :

• La collecte, l'analyse et le suivi des cas de pharmacovigilance.
• L'évaluation médicale et scientifique des événements indésirables.
• La saisie, le codage et la gestion des données de sécurité dans les bases de données dédiées, notamment Argus Safety.
• La détection, l'évaluation et le suivi des signaux de sécurité.
• La préparation et la soumission des déclarations réglementaires auprès des autorités de santé dans les délais requis.
• La contribution à la rédaction et à la revue des documents de pharmacovigilance : PSUR/PBRER, DSUR, RMP, SOPs, rapports de sécurité et autres documents PV.
• La participation aux activités de réconciliation et de contrôle qualité des données de sécurité.
• Le suivi de la conformité aux exigences réglementaires françaises, européennes et internationales.

Requirements

Profil recherché

Rejoignez Excelya, où l’audace, l’attention portée aux autres et l’énergie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Ce poste représente une opportunité stimulante de rejoindre une équipe dynamique et ambitieuse. Vous jouerez un rôle clé dans le domaine qualité en pharmacovigilance, vous garantissez la conformité des processus et contribuez activement à l’amélioration continue, en lien étroit avec les parties prenantes internes et externes.

Vos missions principales :

• Assurer la gestion qualité des déviations PV (RCA, CAPA, conformité des processus et délais).
• Identifier les risques qualité et mettre en œuvre des actions correctives adaptées.
• Contribuer à la documentation qualité PV et au plan qualité annuel.
• Soutenir le système qualité (QMS) via le suivi des CAPA, KPI, déviations et changements.
• Participer aux audits/inspections et garantir la conformité des partenaires et fournisseurs.

Requirements