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 join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth

Mains Responsibilities :

The position involves performing as Local Contact Person responsible for Pharmacovigilance for Belgium and the Netherlands and participating in local/global projects within the Pharmacovigilance (PV) and Safety department.

Work in several aspects of pharmacovigilance shall be expected, such as

·       Performs local literature search/review or quality control on results, maintain local journal/conference lists

·       handles case reports, complaints, queries (from collection to reporting to Client/Authorities)

·       Prepares/reviews aggregate reports (e.g. PSURs/PBRERs)

·       Prepares Risk Management Plans

·       Assists in handling/monitoring additional risk minimisation activities

·       Maintenance of the PV System

·       Participate in/conduct trainings

·       Participate in audits/inspections

About the Job

Join Excelya as a Business Expert: Documentary System Project Manager and take a leading role in the transformation of clinical research documentation processes across our organization. You will spearhead initiatives aimed at enhancing our documentary systems, ensuring compliance with regulatory requirements, and improving operational efficiency.

In this strategic position, you will engage with various stakeholders to gather requirements, analyze current processes, and implement innovative solutions that streamline project activities.

Main Responsibilities:

Are you passionate about digital transformation and regulatory excellence in R&D?

We’re looking for a Document Management & Systems Lead to manage and optimize the document management platforms, ensuring high standards of compliance and efficiency.

You’ll act as the bridge between science, quality, and technology, leading key projects that shape the future of documentation in pharmaceutical research.

1) Functional administration:

• Functional administration of the databases

• Follow up of issues and improvements

• Management of evolution and releases as Business Expert

• Follow-up of the system validation status

• Redaction of SOP and training materials

• User assistance

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.

As an Account Manager, you will be responsible for the retention, satisfaction, and growth of a portfolio of 5 to 10 strategic accounts among our Top-20 clients. Acting as the primary point of contact, you will ensure a 360° view of each account, strengthen relationships with senior stakeholders, and identify opportunities to expand our collaboration.

Main Responsibilities

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 in Clinical Operations. You will be responsible for monitoring clinical studies and ensuring compliance with regulatory requirements, while supporting investigators and site staff to ensure the safety and integrity of participants.

Main Responsibilities:

• Perform closeout visits in accordance with study protocols and GCP guidelines.
• Ensure timely and accurate collection of study data, including on-site source data verification.
• Assist in the preparation of monitoring reports, ensuring compliance with internal and external standards.
• Provide training to site staff on protocol requirements, data entry, and study procedures.
• Communicate effectively with study teams and site personnel regarding study progress and challenges.
• Identify and resolve issues that may impact the integrity of data or the rights and safety of participants.
• Support the preparation for audits and inspections, maintaining compliance at the site level.

Requirements

About You:

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.

As a Mission Safety Member, you will be entrusted with specific responsibilities for product safety management (in pharmacovigilance) on behalf of Excelya clients.

This role offers the opportunity to contribute to meaningful projects, ensuring compliance and patient safety across diverse regulatory environments.

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 Excelya Pharmacovigilance and Safety department. You will play a critical role in ensuring patient safety and driving excellence in pharmacovigilance, while enjoying a dynamic professional environment that fosters learning, collaboration, and career growth.

The Safety Project Leader is the project manager of the PV & Safety team, responsible for the implementation/provision of the activities/services described within a project/service agreement.

Safety Project Leaders are assuming full ownership of their assigned projects, which means they are fully responsible of regular contact with client and where applicable of budget (including budget forecast), invoicing, all legal issues (renewals, closures, extensions, scope etc.), quality and efficiency as well as audit readiness.

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 in Safety. 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 Activities:

• Develop and maintain SAS programs for the reporting and analysis of clinical trial data.
• Collaborate with statisticians and clinical data managers to ensure statistical integrity of the results.
• Conduct exploratory statistical analyses and prepare summary statistics and tables as required.
• Create and validate datasets, ensuring accuracy and consistency across all outputs.
• Support ad-hoc requests for data analysis and create programming specifications.
• Participate in the development of programming practices and standards to improve efficiency and accuracy.
• Document work processes and ensure compliance with regulatory standards.
• Assist in the preparation of regulatory submissions as needed.

Requirements

About You

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.

We are looking for a Data Manager - Research to join our talented team and play a key role in managing clinical data for various research projects, ensuring high quality and consistency across all data collected.

Main Responsibilities:

Organize and improve data quality per rules set by Data Owner.

• Document data, metadata, lifecycle (catalog, contracts, process map)
• Apply data quality rules, automate, monitor flows/reporting
• Implement data integrity rules
• Ingest data to cloud platform (GCP), communicate with stakeholders
• Integrate new assets, Write data transfer specs; Perform quality controls
• Handle data access/migration/archiving
• Apply licensing terms for external data; Main contact for external data providers
• Harmonize/standardize/prepare data for analysis
• Share best practices with the DM community

Deliverables:

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Data Manager – CMC (Chemistry, Manufacturing, and Controls) to support our commitment to high-quality products. In this vital role, you will oversee and ensure the integrity of data generated. You will work closely with research and project teams to deliver actionable insights through rigorous data management practices.

Main Activities:

Organize and improve data quality per rules set by Data Owner.

About the Job

Excelya is looking for a dedicated Data Analyst R&D to join our dynamic Research and Development team. In this role, you will play an essential part in transforming complex data into actionable insights that drive our innovative projects and strategies.

As a Data Analyst, you will collaborate with cross-functional teams to analyze and interpret data from clinical trials, enabling informed decision-making and advancing our mission to improve patient outcomes.

Main Responsibilities:

• Create data visualization solutions.
• Define, specify, build, and/or improve:
• Data structures necessary for storage and analysis: core models, business views, and ad hoc tables (in DBT).
• Reports, dashboards, and data visualizations.
• Unit tests and validation on data preparation, reports, and dashboards.

Deliverables:

• Data preparation: core models, business views, and ad hoc tables (specifications + development and feeding of structures).
• Data analysis and visualization: Data Report, Dashboard, Scoring board, etc.
• Validation reports.

Requirements

About You

We are looking for passionate individuals who thrive in a collaborative environment and are eager to contribute to impactful projects.