Jobs at Excelya

Lead Excelya’s local pharmacovigilance function in Romania, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, and quality-system effectiveness. Serve as the primary contact for health authorities and lead audits, inspections, investigations, CAPAs, training, and inspection readiness. Collaborate with cross-functional teams and vendors while driving regulatory intelligence, risk identification, and continuous improvement of local PV operations.

Lead and manage the QA Vigilance & Compliance team to define and implement quality and compliance requirements for vigilance activities. Ensure regulatory compliance (GVP, GMP, ISO), provide quality oversight, manage audits and external partner QA, support regulatory inspections (ANSM, FDA), monitor KPIs, and drive continuous improvement and regulatory intelligence.

Lead Excelya’s local pharmacovigilance function, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, quality systems, audits, inspections, CAPAs, training, vendor oversight, and inspection readiness. Serve as the primary contact for health authorities and drive continuous improvement through regulatory intelligence, risk identification, and stakeholder collaboration. This is a part-time freelancer role requiring German and English fluency and EU residency.

Lead the local pharmacovigilance function in Slovakia, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, quality systems, audits, inspections, CAPAs, training, vendor oversight, and inspection readiness. Serve as the primary pharmacovigilance contact for health authorities and drive continuous improvement through regulatory intelligence, risk identification, and cross-functional collaboration.

Leads the local pharmacovigilance function, ensuring regulatory compliance and effective safety governance. Serves as the primary contact for Health Authorities and leads inspections, audits, and regulatory interactions. Oversees case management, signal detection, risk management, reporting, quality systems, CAPAs, training, vendor collaboration, and inspection readiness. Drives continuous improvement through risk identification, regulatory intelligence, and stakeholder engagement.

Leads the local pharmacovigilance function, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, quality systems, CAPAs, training, audits, inspections, vendor oversight, and stakeholder engagement. Serves as the primary pharmacovigilance contact for health authorities and drives continuous improvement and inspection readiness.

Leads Hungary’s local pharmacovigilance function, ensuring regulatory compliance, safety monitoring, case management, signal detection, risk management, reporting, quality systems, audits, inspections, CAPAs, training, vendor oversight, and inspection readiness. Serves as the primary contact for Health Authorities and drives continuous improvement through regulatory intelligence, risk identification, and cross-functional collaboration.

Work with multidisciplinary teams to integrate and analyze large heterogeneous scientific datasets, develop data processing pipelines, build and deploy ML and predictive models, apply AI and mathematical/systems biology models to support in silico drug design, molecular selection and optimization, and contribute data-driven insights to translational research.

As an Oracle Programmer II, you will provide programming input for data management activities, ensuring adherence to client SOPs and quality standards.

As an Oracle Programmer, you'll provide programming support for Data Management, implement data integrations, and ensure quality in clinical programming activities according to client specifications.

Lead integration of QMS and documentation for a site transfer, harmonize SOPs and processes, manage training and change management, oversee CAPAs/Change Controls/deviations, track KPIs and project timelines to ensure GMP compliance and successful delivery.

Lead enhancement of Benefit-Risk Assessment & Management practices, oversee signal detection and safety writing workflows, drive capability-building and transformation projects, implement SOP and process improvements, ensure regulatory compliance, and collaborate with IT on automation and AI-enabled solutions.

Lead design, deployment, and continuous improvement of the Commercial Operations QMS to ensure global GxP compliance. Manage quality documentation, CAPAs, deviations, audits/inspection readiness, training, risk registers, supplier oversight, QTAs, and APQR communication while coordinating cross-functional and external partner remediation and improvement activities.