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

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.

The eTMF Specialist plays a key role within the Clinical Development Platform by ensuring the quality, compliance, and inspection readiness of the electronic Trial Master File (eTMF) across global clinical trials.

This role requires strong expertise in clinical documentation management, close collaboration with cross‑functional teams, and active involvement in audits and inspections within a regulated environment.

Key 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 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

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 Medical Affairs. 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.

The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents).

The Medical Writer will draft the reference documents for clinical studies, other research involving the human person and research not involving the human person and which must be part of the authorization request file from the Competent Authorities, such as the protocol, the summary of the protocol, the information and consent form, the observation booklet and any patient questionnaires and the investigator brochure.

The Medical Writer will work alongside healthcare professionals, project managers, statisticians and other company functional groups to produce the medical writing deliverables.

Main 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.

This role is an exciting opportunity to contribute to a dynamic, 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:

• Ensure quality review of safety data received from partners before entry into the safety database (completeness, accuracy, compliance).
• Oversee serious adverse event (SAE) management, including coordination and review of case narratives.
• Perform quality checks of aggregate reports (e.g., DSURs).
• Support PV setup for clinical studies and implementation of safety processes.
• Manage PV documentation in eTMF to ensure inspection readiness.
• Contribute to the setup of post-marketing PV systems.
• Collaborate with internal teams and partners to ensure efficient and compliant safety operations.

Requirements

At Excelya, we embody Audacity, Care, and Energy in all that we do. We offer a dynamic and inclusive environment where innovation and collaboration drive success.

The Medical Reviewer provides medical and operational oversight of global pharmacovigilance review activities, ensuring high-quality assessment of ICSRs, compliance with regulatory requirements, and submission readiness for critical cases. The role also supports the continuous improvement and consistency of medical review processes, maintaining alignment with internal quality standards and global regulations.

Main Responsibilities:

• Perform medical review of ICSRs ensuring completeness and submission readiness.
• Manage complex/high-priority cases with appropriate clinical assessment.
• Ensure data quality and consistency in the safety database.
• Conduct targeted QC activities and drive corrective/improvement actions.
• Lead follow-up activities with internal teams, HCPs, and vendors.
• Oversee coding standards (MedDRA, WHO Drug) and ensure global consistency.
• Contribute to PV standards, training, and continuous improvement.
• Support benefit-risk evaluation and safety strategy activities.
• Act as SME for audits and inspections.
• Manage processes, vendors, and KPIs, driving operational performance.

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 ensures continuous improvement of processes, systems, and compliance across key PV activities.
It also supports inspection readiness, PSMF management, and partner oversight, requiring strong PV and regulatory expertise.

Main Responsibilities:

• Lead transformation projects to drive innovation and excellence across Global Pharmacovigilance (GPV).
• Deliver short- and mid-term initiatives, ensuring effective implementation of outcomes (process and SOP improvements).
• Drive capability-building initiatives, including development of methodologies, tools, and frameworks.
• Manage projects end-to-end, including planning, tracking milestones, and stakeholder communication.
• Support and enhance GPV infrastructure, including procedures, data flows, tools, and documentation.
• Collaborate with IT to advance digital solutions, automation, workflow optimization, and AI integration.
• Ensure compliance across key PV activities, including case processing, safety systems, and local operations.
• Contribute to PSMF maintenance, inspection readiness (CAPA, deviations), and partner management.

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:

• Supervise pharmacovigilance case management outsourced to assigned platform(s)
• Respond to case-related emails and inquiries from external service providers
• Monitor case processing timelines and investigate any delays in reporting or transmission
• Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
• Support the review and validation of clinical study case narratives for inclusion in study reports
• Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
• Oversee reconciliation of cases with clinical databases managed by outsourced providers
• Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

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 freelance part-time role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance Department. 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.

About the job:

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

Main Responsibilities: