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 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:

Redefine Pharmacovigilance. Empower Innovation. Build with Audacity.

Join Excelya as Our Next PV Star!

At Excelya, we don’t just work, we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience.

Now, we’re calling on curious minds and courageous spirits to step into a career-defining role in Pharmacovigilance. Ready to make an impact that travels the globe? Let’s talk.

About the Job

We are seeking a Safety Officer who will be performing as Local Contact Person responsible for Pharmacovigilance for BeNeLux and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.

Your Mission:

Redefine Pharmacovigilance. Empower Innovation. Build with Audacity.

Join Excelya as Our Next PV Star!

At Excelya, we don’t just work, we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience.

Now, we’re calling on curious minds and courageous spirits to step into a career-defining role in Pharmacovigilance. Ready to make an impact that travels the globe? Let’s talk.

About the Job

We are seeking a freelancer Pharmacovigilance Specialist who will be assigned to specific responsibilities for the handling of product safety (e.g. pharmacovigilance, device or cosmeto- vigilance) or other issues for a Client of Excelya PV & Safety. Will perform in compliance with the client’s and/or EXCELYA’s SOPs and where applicable as per client’s job description.

Your Mission:

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 :