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 company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Safety Partner, you will be responsible for supporting and implementing product safety strategies for a portfolio of products primarily used in autoimmune diseases. Working closely with local and global stakeholders, you will contribute to the continuous monitoring of product benefit-risk profiles, support signal management activities, and ensure compliance with pharmacovigilance requirements while helping identify unmet patient and healthcare professional needs.

Main responsibilities :

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

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

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 Pharmacovigilance Associate ensures drug safety compliance by managing safety reports, supporting risk management activities, and communicating with stakeholders. The role requires a life sciences background, pharmacovigilance experience, and strong organizational, communication, and teamwork skills.

Main responsibilities:

• Ensure compliance with pharmacovigilance regulations, company procedures, and quality standards.
• Manage Individual Case Safety Reports (ICSRs) in accordance with local legislation and internal guidelines.
• Communicate relevant safety information to health authorities, stakeholders, and external partners.
• Support safety surveillance activities, including risk management, safety issues, and product-related alerts.
• Contribute to the creation and maintenance of quality documents and ensure proper documentation practices.
• Deliver training on pharmacovigilance processes to internal employees.
• Collaborate with third parties involved in pharmacovigilance activities.
• Promote adherence to corporate policies, values, and compliance standards, including HSE requirements.

Requirements

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Clinical Scientist, you will be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

• Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
• Contribute to the preparation and review of protocols, informed consent forms, and amendments.
• Perform medical review of clinical data, including patient profiles and adverse event narratives.
• Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
• Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
• Ensure proper documentation and filing of study-related materials into Trial Master Files.
• Support preparation for audits, inspections, and regulatory submissions.

Requirements

About You

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

About the Job

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Clinical Scientist, you will be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

• Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
• Contribute to the preparation and review of protocols, informed consent forms, and amendments.
• Perform medical review of clinical data, including patient profiles and adverse event narratives.
• Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
• Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
• Ensure proper documentation and filing of study-related materials into Trial Master Files.
• Support preparation for audits, inspections, and regulatory submissions.

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