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

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

Excelya is looking for a motivated Quality Safety Officer to join our dedicated Safety 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 quality control activities related to pharmacovigilance processes, ensuring compliance with global regulatory requirements, internal procedures, and industry standards while contributing to continuous quality improvement and patient safety.

Key Responsibilities:

• Perform quality control reviews of pharmacovigilance cases to ensure accuracy, completeness, and regulatory compliance.
• Ensure consistency and reliability of safety data entered in pharmacovigilance databases.
• Manage and navigate pharmacovigilance databases to support case review, follow-up, and data quality activities.
• Gain proficiency in internal processes and workflows to ensure compliance and operational excellence.
• Contribute to the continuous improvement of pharmacovigilance quality processes and documentation standards.

Requirements

Education: Bachelor’s degree in Life Sciences, Pharmacy, or a health-related field. Additional training or certification in Pharmacovigilance or Quality Management is a plus.

About Excelya

Excelya is a fast-growing European CRO driven by the ambition to deliver the most engaging employee experience while becoming a leading player in clinical research. With more than 1,000 employees across 28 countries, we continue to expand and strengthen our organisation.

As part of this growth, we are looking for a Business Manager to contribute to the development of one of our strategic Business Units dedicated to Clinical Research and Life Sciences activities.

Your Mission

As a Business Manager, you will play a key role in the commercial development, consultant management, and client relationship management of your business perimeter, while contributing actively to Excelya’s growth strategy.

Your responsibilities will include:

Business Development & Client Management

• Identify and develop new business opportunities through active prospecting and networking activities
• Conduct client meetings, qualify needs, promote Excelya’s expertise and manage commercial negotiations
• Build long-term partnerships with clients and ensure a high level of satisfaction
• Participate in business reviews and strategic meetings with key stakeholders
• Promote Excelya’s expertise across Clinical Operations, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing and Medical Affairs activities

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:

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:

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: