Enovalife

About the Company

Enovalife (formerly known as Business & Decision Life Sciences) is part of the Orange Business Group, an international consulting and Systems Integration company listed on the Eurolist C exchange.

Enovalife is specialized in the delivery of services and provision of solutions in the Life Sciences industry. With 25 years of experience, it supports its clients in the pharmaceutical, medical device, biotechnology, food and cosmetics industries.

Core skills include the provision of a range of expert CRO and consulting services (supporting clinical trials in the operational, data management, analytical, outcome research, and document writing area) and the implementation of technology-based, clinical applications and solutions tailored for the Life Sciences industry.

Enovalife is also a partner in the digital transformation of the pharmaceutical industry. Drawing on the expertise of the Orange Group, we carry out projects ranging from the collection of health data to the implementation of digital solutions for our customers.

Enovalife has offices in France and in Belgium and provides services all over Europe.

Listed Jobs

Company Name

Enovalife

Job Title

Administrateur de Base de Donnees Fonctionnelle PV F/H

Job Description

**Job Title:** Functional Database Administrator – Pharmacovigilance (PV) F/H **Role Summary:** Responsible for the functional administration of the pharmacovigilance database, responding to internal and external stakeholder requests, supporting E2B electronic exchange setups, maintaining database integrity, and contributing to Business Objects reporting solutions. **Expectations:** - Deliver timely database configuration changes and updates. - Ensure smooth operation of E2B exchanges and resolve related incidents. - Keep the database in an operational state by monitoring anomalies and implementing enhancements. - Collaborate with business users to define, validate, and verify reporting requirements. **Key Responsibilities:** - Create and update studies, products, and expedited reporting submission rules in the database. - Participate in the implementation and monitoring of new and existing E2B exchanges with authorities and partners. - Track and resolve database anomalies; manage evolution requests. - Gather and document Business Objects reporting needs; support development, validation, and verification of reports. - Provide additional pharmacovigilance support tasks as assigned by management. **Required Skills:** - Proven experience with the Argus pharmacovigilance database. - Strong knowledge of pharmacovigilance regulatory tools and processes. - Familiarity with E2B electronic exchange standards and incident management. - Experience with Business Objects or similar reporting tools. - Excellent analytical, problem‑solving, and communication skills. - Ability to work cross‑functionally with global safety and local teams. **Required Education & Certifications:** - Bachelor’s degree in Life Sciences, Pharmacy, Computer Science, Information Systems, or related field (Master’s preferred). - Formal training or certification in Pharmacovigilance (e.g., GVP, GCP) is desirable. - Relevant database or data management certifications (e.g., SQL, data modeling) are a plus.

Paris, France

On site

20-10-2025

Company Name

Enovalife

Job Title

Chef de projet VSI F/H

Job Description

**Job Title**: Validation Project Manager **Role Summary**: Lead validation of computerized systems in regulated industries (pharmaceutical, cosmetic, biotech), ensuring compliance with quality standards and regulatory requirements. **Expectations**: Define and implement validation strategies, coordinate cross-functional teams, support new system implementation, and maintain ongoing compliance through routine reviews and documentation. **Key Responsibilities**: - Develop and execute validation strategies aligned with GAMP 5, Annex 11, and 21 CFR Part 11. - Author and approve validation deliverables (URS, traceability matrices, risk assessments, IQ/OQ/PQ protocols, validation reports). - Collaborate with IT, Quality, Production, and vendors to manage system validation and integration. - Identify user and regulatory requirements for new systems (MES, WMS, LIMS, SCADA). - Oversight of system implementation, qualification, and user training on data integrity practices. - Conduct periodic system reviews, CAPA follow-ups, and maintain validated documentation to quality standards. **Required Skills**: - Validation strategy development and execution. - Stakeholder coordination across departments and suppliers. - Technical writing of validation documentation. - Regulatory compliance (GAMP 5, 21 CFR Part 11, BPF principles). - Experience with quality management systems (QMS) and change control processes. **Required Education & Certifications**: - Bachelor’s or master’s degree in computer science, engineering, biotechnology, pharmacy, or equivalent. - Minimum 2 years’ experience in computerized systems validation within regulated industries. - Technical English proficiency advantageous.

Annecy, France

Hybrid

22-10-2025

Company Name

Enovalife

Job Title

Expert Bio-Informatique F/H

Job Description

**Job Title**: Bioinformatics Consultant (Expert) **Role Summary** Provide technical leadership and methodological support across the entire genome‑data lifecycle, from analysis strategy to GMP batch release. Design, implement, and maintain cloud‑based pipelines, qualify sequencing instruments, and deliver training and SOPs to laboratory teams. **Expectations** - Serve as the primary bioinformatics point of contact. - Own end‑to‑end data management, ensuring compliance with GMP and regulatory standards. - Mentor lab staff and promote best practices in data analysis and interpretation. **Key Responsibilities** 1. **Infrastructure & Pipeline Development** - Design and deploy cloud storage and compute platforms for bioprocessing workloads. - Develop standardized HTS analysis pipelines (Illumina, Oxford Nanopore) using Snakemake. - Create and enforce analysis strategies, tool benchmarking, and data quality metrics. 2. **Operational Support & Compliance** - Aggregate pipelines for plasmid identification and microbial screening. - Qualify sequencing hardware and analytical methods: protocol writing, execution, risk analysis, and reporting. - Analyze GMP and non‑GMP batches; maintain pipeline versioning and transfer to other teams. 3. **Training & Documentation** - Update and deliver SOPs, user guides, and training sessions to laboratory technicians. - Provide ongoing user support for data interpretation and troubleshooting. **Required Skills** - Advanced proficiency in High‑Throughput Sequencing (QC, trimming, alignment). - Cloud computing/GPU usage with Linux (bash) expertise. - Strong scripting in Snakemake, Python, R, or Rust; workflow orchestration. - Familiarity with genome annotation, structural prediction, and data visualisation tools (IGV, jBrowse, CLC Genomics, Geneious). - Solid understanding of bacterial genomics and eukaryotic transcription. - Fluent in English, both written and spoken. **Required Education & Certifications** - Bachelor, Master, or Engineer degree in Bioinformatics, Computational Biology, Genomics, or related field. - Proven experience in a regulated (GMP) environment is essential.

Lyon, France

On site

27-11-2025