Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Key responsabilities:

• Perform the medical review and assessment of sensitive and complex pharmacovigilance cases based on source documents and medical records.
• Analyze case documentation to identify, extract and evaluate relevant medical information in accordance with applicable procedures and guidelines.
• Contribute to the medical and scientific evaluation of safety cases, ensuring the completeness, consistency and accuracy of collected data.
• Collaborate closely with Pharmacovigilance Operations teams to support case processing activities.
• Review documentation to identify potential duplicate cases and support their assessment in collaboration with PV teams.
• Identify potential adverse events and ensure their timely communication for entry into the global pharmacovigilance database.
• Assess and communicate significant new safety information and follow-up data arising from additional source documentation.
• Ensure compliance with pharmacovigilance regulations, internal procedures and quality standards.
• Support continuous improvement initiatives related to medical case review and pharmacovigilance processes.

About the Job

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 Medical Affairs. 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.

The Medical Data Officer works in close collaboration with the Study Medical

Reviewer and participates in managing/reviewing the medical consistency of

reported clinical data to ensure that medical data in database are accurate, reliable

and analyzable.

Main Responsibilities

1. Study Setup Tasks

* Protocol Review especially topics linked to safety management, specific data that could need to be coded, inclusion, selection criteria, study design, pathology and mechanism of action of the IMP

* Database specification review and User acceptance test on eCRF, and Database validation tools used for medical review

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to support the systems used for clinical data cleaning and review activities. As a Business System Expert, you will act as the bridge between Clinical Data Management, Medical Review, IT, QA, and system vendors, ensuring optimal performance, compliance, and adoption of clinical data management platforms.

Key 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

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to join a dynamic and ambitious team.

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

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 is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs. 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. 

The Study Medical Reviewer is accountable for managing/reviewing the medical consistency of reported clinical data to ensure that medical data in database are accurate, reliable and analyzable. He/Her has the responsibility of his/her studies/projects to provide reliable and consistent data from a medical point of view and to bring medical expertise to all processes from the set-up to the lock of the study.

Main Responsibilities