Excelya is looking for a motivated Clinical Trial Assistant to join our dedicated Clinical Operations team. As part of our company values of Audacity, Care, and Energy, you will contribute to advancing innovative clinical trials that improve patient outcomes.

In this role, you will oversee all aspects of clinical trials from site initiation to close-out, ensuring compliance with protocols and regulations while building strong relationships with study investigators and site staff.

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.

This role offers a great opportunity to contribute to a strategic EDMS transformation program within a global Quality environment. You will play a key role in analyzing complex data landscapes, supporting data-driven decision-making, and shaping the document migration strategy, while working in a highly collaborative and intellectually stimulating environment.

Key responsibiliities :

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

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

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.

Main responsibilities :

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.

Main responsibilities :

Define and lead the CMC regulatory strategy for complex projects, providing proactive guidance and expertise to cross-functional technical teams

Develop and maintain a global regulatory roadmap, ensuring alignment between manufacturing changes, regulatory requirements, and supply chain constraints

Oversee the preparation and submission of CMC dossiers, ensuring the robustness of comparability, validation, and quality data

Coordinate global regulatory submissions, optimizing timelines and ensuring compliance with regional requirements

Lead and manage interactions with Health Authorities, including addressing technical questions and supporting negotiations to facilitate approvals

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

Tiger Analytics is an advanced analytics consulting firm. We are the trusted analytics partner for several Fortune 1000 companies, enabling them to generate business value from data. Our consultants bring deep expertise in Data Science, Machine Learning and AI. Our business value and leadership has been recognized by various market research firms, including Forrester and Gartner.

We are seeking a Senior Manager / Associate Director with a strong Life Sciences background and hands-on commercial analytics experience to launch Commercial Data Product to support an upcoming pharma launch. This role will lead a small, dedicated pod to design and build a Snowflake-native, Power BI–aligned data product from the ground up. The position gives an opportunity to focus on data product ownership, metric design, and stakeholder alignment. The candidate should have strong experience and domain knowledge in gene therapy, with exposure to relevant processes, workflows, and industry applications.

Key Responsibilities

Tiger Analytics is an advanced analytics consulting firm. We are the trusted analytics partner for several Fortune 1000 companies, enabling them to generate business value from data. Our consultants bring deep expertise in Data Science, Machine Learning and AI. Our business value and leadership has been recognized by various market research firms, including Forrester and Gartner.

We are seeking a Senior Manager / Associate Director with a strong Life Sciences background and hands-on commercial analytics experience to launch Commercial Data Product to support an upcoming pharma launch. This role will lead a small, dedicated pod to design and build a Snowflake-native, Power BI–aligned data product from the ground up. The position gives an opportunity to focus on data product ownership, metric design, and stakeholder alignment. The candidate should have strong experience and domain knowledge in gene therapy, with exposure to relevant processes, workflows, and industry applications.

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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory. 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: