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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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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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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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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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Clinical Research Associate (CRA) - Oncology - Clinical Operations

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.

In this hands-on role, you will support site activation, documentation, regulatory submissions, and ensure TMF quality and inspection readiness. Working closely with cross-functional teams, you will help drive efficient study execution while maintaining full compliance with regulations and internal standards.

Main Responsibilities:

Job Skills

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Scientifique PKPD

posted by: spj_bot

About the Job

Excelya is seeking a skilled Pharmacokineticist to join our dynamic team. You will play a key role in supporting the pharmacokinetic (PK) evaluation of clinical trials across all phases, contributing to drug development and regulatory submissions.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation.

Key Responsibilities:

Job Skills

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Clinical Research Director

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As the Clinical Research Director for Inflammation and Immunology (I&I), you will lead critical clinical programs and play a pivotal role in advancing innovative therapies for patients.

This remote role empowers you to influence clinical strategy significantly, ensuring that we not only meet regulatory standards but also create optimal study designs that translate into successful patient outcomes.

Main Responsibilities:

Lead the clinical development of projects in the Inflammation and Immunology therapeutic area from inception through to the successful execution of clinical trials

Ensure compliance with regulatory requirements, ICH-GCP principles, and internal procedures throughout the trial lifecycle

Develop and approve key clinical documents including protocols, informed consent forms, and study amendments

Work closely with cross-functional teams to define clinical strategy, operational processes, and delivery timelines

Serve as the primary medical and scientific contact for Health Authorities, Ethics Committees, investigators, and key stakeholders

Oversee and guide the design, governance, and conduct of clinical committees, ensuring adherence to governance standards

Job Skills

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Quality Safety Officer

posted by: spj_bot

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.

Job Skills

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Clinical Operations Lead

posted by: spj_bot

About the Job

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 a dedicated team while collaborating with various stakeholders to uphold the highest standards of quality in clinical operations. You will be instrumental in driving innovation and contributing to cutting-edge research initiatives that shape the future of healthcare.

Main Responsibilities

Job Skills

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Oracle Programmer II

posted by: spj_bot

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 Data Management. 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 Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.  

 

Main Responsibilities

Job Skills

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