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Global Safety Officer Senior

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.

You will be responsible for the medical assessment of sensitive pharmacovigilance files, often consisting of numerous medical documents. Expertise in neurology, obstetrics‑gynecology, or pediatrics is particularly valuable.

Your role will be to produce clear, accurate, and clinically rigorous medical summaries, supporting medico‑legal evaluations within the context of compensation requests.

Main Responsibilities:

Job Skills

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Clinical Quality Assurance Officer

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define how we support our clients and how we grow together. We believe in building bold solutions and fostering an inclusive environment where collaboration, responsibility, and personal development are central.

This role is an exciting opportunity to join our Clinical Quality Assurance team. As a key contributor, you will ensure that clinical research activities are conducted in full compliance with international regulations, internal standards, and industry best practices. You will help drive continuous improvement, strengthen our quality culture, and support teams through a stimulating and supportive professional environment.

Main Responsibilities:

Job Skills

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Senior Qualification Specialist - Pharmaceutical Manufacturing

posted by: spj_bot

About the Job

As a Gidy Expert Qualification at Excelya, you will be at the forefront of ensuring compliance and qualification for innovative solutions within the biopharmaceutical landscape. This unique role involves a deep understanding of regulatory standards and the application of best practices in qualification processes.

You will work closely with our teams to design, implement, and optimize qualification protocols that align with our clients' needs and maintain the highest quality and safety standards in their processes.

Main Responsibilities:

Job Skills

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Technical Data Manager I

posted by: spj_bot

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 Technical Data Manager, who will be responsible for performing Technical Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs.

Main Responsibilities:

Job Skills

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Senior Medical Writer

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 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.

Main Responsibilities

  • Act as lead author for a range of regulatory and scientific documents (clinical protocols, Investigator Brochures, CTD modules, informed consent forms, etc.).
  • Coordinate cross-functional input (clinical, regulatory, biostatistics, data management, etc.) to ensure consistency and scientific accuracy of all deliverables.
  • Oversee and review the work of external vendors or contributing writers to ensure quality and compliance.
  • Ensure documents adhere to company SOPs, style guides, and international regulatory standards (EMA, FDA, ICH).
  • Manage timelines, planning, and document reviews efficiently to support submission milestones.

Requirements

About You

Job Skills

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Clinical Data Manager I

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 Bangalore. 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.

Requirements

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

Experience:  

One or more years as a Data Manager or equivalent combination of education, training and experience

Skills:  Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance

    • Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
    • Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)

Education: Bachelor’s degree qualification in a Scientific discipline is preferred

Job Skills

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Lead Biostatistical Programmer

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. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Activities

Job Skills

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Project Data Manager

posted by: spj_bot

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 an Project Data Manager to strengthen our commitment to delivering high-quality products. In this pivotal role, you will lead quality assurance processes, ensure regulatory compliance, and drive continuous improvement initiatives.

Main Activities:

Job Skills

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Senior Quality Engineer (Remote - US)

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Senior Quality Engineer in the United States.

We are seeking a seasoned Senior Quality Engineer to support quality assurance efforts in a fast-paced, highly regulated medical device environment. This role will play a key part in ensuring the quality and compliance of software-based products, including those utilizing AI/ML technologies. The ideal candidate will bring deep knowledge of quality standards, risk management, and regulatory compliance, with a proactive approach to continuous improvement and cross-functional collaboration. The position requires experience with software as a medical device (SaMD) and a strong understanding of ISO and FDA regulations.

Accountabilities:

Job Skills

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IT Business Systems Manager - Quality Systems

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for an IT Business Systems Manager – Quality Systems in the United States.

As the IT Business Systems Manager for Quality Systems, you will act as the IT System Owner for GxP-regulated platforms such as Learning Management Systems (LMS), Quality Management Systems (QMS), and Electronic Document Management Systems (eDMS). Your role will focus on supporting compliance-related applications and partnering closely with Quality and Validation teams to ensure the successful configuration, validation, and operation of systems like Veeva Vault Quality and ComplianceWire. You’ll lead both technical and regulatory aspects of IT system management in a hybrid agile/waterfall environment, driving scalable and compliant technology solutions.

Accountabilities:

Job Skills

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