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Yassine GuarebYG

Yassine Guareb

Data Protection Officer

€850/day
Paris, FR
8-15 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Yassine

With more than 12 years of experience in IT, including 9 years on data protection issues in the Pharmaceutical industry, I have supported several clinical research players as a data expert. From the implementation of complex IS (with operational tests) to the audit of websites and the implementation of CMP solutions (consent management and traceability), I have implemented actions to secure the operation of IS with a risk management approach proportional to regulatory requirements, the life cycle and the value of the data.
I am also open to exploiting my expertise and skills in sectors other than the pharmaceutical industry.
  • English

    Native or bilingual

  • French

    Native or bilingual

  • Arabic

    Native or bilingual

Can work on-site
Paris (up to 50km)

Experience

  • Data Value Protect
    Data protection / IT security expert
    DIGITAL AND IT
    March 2021 - Today (5 years and 5 months)
    Paris, France
    Client support as an independent:
    - External DPO / DPO assistance / inspection preparation
    - Compliance audits (structure, projects, service providers, websites)
    - Data protection / IT security awareness training
    - Implementation of IT security projects
    GDPR Expertise IT Security Audit Risk Analysis
  • Keyrus Life Science
    IT Compliance Manager - Data Protection Officer
    PHARMACEUTICALS INDUSTRY
    April 2016 - April 2021 (5 years)
    Levallois-Perret, France
    Internal missions:
    - Definition of master plan, governance & IT strategy
    - Risk assessment/management of IT security, data storage/availability/archiving, data integrity, IT charter (CISO)
    - Qualification and management of service providers (from benchmark to end of service)
    - ISO 9001/27001 process manager
    - Data protection officer (6 entities, 350 employees): France, Belgium, Tunisia, Lebanon, Canada, USA

    Missions as a consultant:
    - Servier Mission (9 months): integration and acceptance of a big data tool to facilitate data exploration in the R&D context (centralization of genetic data from all clinical studies of the laboratory).
    - Roche Mission (6 months): definition of the regulatory strategy (CNIL submission) and governance of the data centralization project in oncology held by Roche & the Curie Institute in a health data warehouse (security by design).
    - MaaT Pharma Mission (1 month): regulatory compliance audit to IT pharma & data protection standards before FDA submission and fundraising.
    IS Validation GxP GAMP5 21 CFR Part 11 ISO9001 Audit Project Management IT Governance ISO 27001 Data Protection Big Data Risk Management IT Master Plan IT Strategy
  • INSERM - U933 Rare Disease Cohorts (RaDiCo)
    e-Health Project Manager
    PHARMACEUTICALS INDUSTRY
    October 2014 - March 2016 (1 year and 6 months)
    Paris, France
    Missions within the structure:

    - IT architecture design (Big Data)
    - Integration of application solutions & audit of existing databases
    - Implementation of IT security base (pharma standards)
    - Formalization of organizational processes (BPM)
    Project Management IS Validation Data Protection Big Data GAMP5 ICH GCP 21 CFR Part 11 CNIL Risk Analysis IT Governance

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Education

  • Master 2 - Ingénierie Médicale - Génie pour la Santé
    Université Paris VI - Pierre et Marie Curie
    2014
    Formation généraliste Chef de Projet R&D développement de Dispositifs Médicaux

Certifications

  • Data Protection Officer
    PECB
    2019

Skill set

Categories