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Business Analyst - Gestion Documentaire Pharma

posted by: spj_bot

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 offers a great opportunity to contribute to a strategic EDMS transformation program within a global Quality environment. You will play a key role in analyzing complex data landscapes, supporting data-driven decision-making, and shaping the document migration strategy, while working in a highly collaborative and intellectually stimulating environment.

Key responsibiliities :

Job Skills

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Pharmacovigilance manager

posted by: spj_bot

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

Job Skills

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Pharmacovigilance Associate

posted by: spj_bot

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 Pharmacovigilance Associate ensures drug safety compliance by managing safety reports, supporting risk management activities, and communicating with stakeholders. The role requires a life sciences background, pharmacovigilance experience, and strong organizational, communication, and teamwork skills.

Main responsibilities:

  • Ensure compliance with pharmacovigilance regulations, company procedures, and quality standards.
  • Manage Individual Case Safety Reports (ICSRs) in accordance with local legislation and internal guidelines.
  • Communicate relevant safety information to health authorities, stakeholders, and external partners.
  • Support safety surveillance activities, including risk management, safety issues, and product-related alerts.
  • Contribute to the creation and maintenance of quality documents and ensure proper documentation practices.
  • Deliver training on pharmacovigilance processes to internal employees.
  • Collaborate with third parties involved in pharmacovigilance activities.
  • Promote adherence to corporate policies, values, and compliance standards, including HSE requirements.

Requirements

Job Skills

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Clinical Operations Consultant

posted by: spj_bot

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:

  • Support the operational management of ongoing clinical studies.
  • Contribute to study oversight and coordination activities.
  • Collaborate with internal and external stakeholders, including CRO partners and study teams.
  • Ensure compliance with applicable regulations, GCP and study procedures.
  • Assist with workload management and operational delivery during a peak activity period.

Requirements

Job Skills

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Research Assistant

posted by: spj_bot

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.

As a Research Assistant in Histopathology, you will contribute to the preparation, processing, and analysis of biological tissue samples to support research projects across various therapeutic areas.

Key responsibilities include:

Job Skills

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Laboratory Technician (Clinical Biology)

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.
As a Laboratory Technician, you will play a key role in supporting preclinical clinical biology activities, contributing to the generation of high‑quality biological data in a translational research environment.

You will be involved in laboratory analyses, data quality control, and the continuous improvement of laboratory processes within a regulated R&D setting.

Key Responsabilities :

  • Receive, verify, and prepare biological samples (blood, plasma, serum, urine) according to established procedures
  • Perform analyses using hematology and biochemistry automated systems
  • Conduct data quality checks before validation and ensure data reliability
  • Participate in equipment maintenance and calibration
  • Contribute to the drafting and updating of SOPs and operational procedures
  • Support the development and validation of new biomarker assays (e.g. ELISA)
  • Ensure compliance with quality standards and laboratory proced

Requirements

About You

Job Skills

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CMC Leader

posted by: spj_bot

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.

Main responsibilities :

Job Skills

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Clinical Scientist Oncologie

posted by: spj_bot

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

Job Skills

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Regulatory Affairs Export Manager (Cosmetics)

posted by: spj_bot

About the Job

Excelya is seeking a motivated Regulatory Affairs Export Manager specializing in Cosmetics. Join a vibrant and ambitious team driven by Audacity, Care, and Energy, where your contributions will directly impact the global distribution and regulatory compliance of cosmetic products.

As the Regulatory Affairs Export Manager, you will oversee the regulatory strategies essential for exporting cosmetics to various international markets. Your expertise will ensure that our products meet the regulatory requirements of target countries, enabling successful market access and growth.

Main Responsibilities:

Job Skills

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Clinical Scientist

posted by: spj_bot

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

Job Skills

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