24 set - Milano
Philogen
Philogen S.p.A. is a biotechnology company dedicated to developing targeted products for the imaging and treatment of life-threatening diseases, with a strategic focus on oncology. Our mission is to translate cutting-edge scientific innovation into effective therapies that improve patients’ lives.
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Position Overview
We are looking for a Life Sciences Solutions Engineer who combines strong coding skills with deep expertise in at least one of the following areas:
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- Pharmaceutical quality systems or quality control.
- GxP, computerized-system compliance, or regulated software validation.
- Clinical trial operations, clinical data management, or trial oversight.
This is not a documentation-only compliance role. You will inspect data, write code, configure and test systems, and work directly with engineers, clinical teams, quality specialists, and business stakeholders. You will guide the introduction of production-grade AI and data systems into regulated workflows.
What You Will Do
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- Translate pharmaceutical and clinical requirements into implementable data models, workflows and access rules.
- Guide software deployment through the applicable quality, privacy, security, and regulatory requirements.
- Determine which regulatory frameworks apply to each use case rather than treating every healthcare system as subject to identical controls.
- Analyse clinical trial data covering studies, sites, subjects, visits, forms, observations, queries, reviews, medical coding, and audit history.
- Define and test controls for sensitive information, including role-based access, separation of duties, approvals, and audit trails.
- Produce and maintain documentation such as intended-use definitions, risk assessments, traceability matrices, validation plans, test evidence, operating procedures, and change records.
- Work with quality, clinical, security, legal, and engineering stakeho
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