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Stefaan ROOBAERT

  • SGS Belgium NV
  • Head Contract Management

Mâlines

En résumé

Experienced in different process areas of Pharmacovigilance, Quality Assurance, Clinical Project Management, Contract and Budget Management, bringing a global, integrated, transversal, cross-functional quality project perspective.
High quality, ethics and self-started mind set, interested in supporting quality and business activities by exploring new areas, analyzing, evaluating, setting up new processes, systems or seeking process improvements in various cross-functional domains with multidisciplinary and multilingual teams.
Able to work with a sense of urgency, in a fast-paced, complex and challenging regulated environment.
Mobile for short/long term opportunities and travel in Europe.
Mother tongue French

Mes compétences :
Assurance qualité
Audit qualité
Pharmacovigilance
Project Management Office
Audit
Clinical Trials
Quality Assurance
Clinical Trial Monitoring
Clinical Project Management
Process Improvement
Budget/Contract Management
Case Report Forms
GCP / GVP
Standard Operating Procedures

Entreprises

  • SGS Belgium NV - Head Contract Management

    Administratif | Mâlines 2021 - 2022

  • Kalicoop - Clinical Research, Quality, Pharmacoviglance Consultant

    2013 - 2020 - Pharmacovigilance Alliance Lead Consultant, Pharmacovigilance Partnering Department (6 m) – Home based.
    - Pharmacovigilance Licensing Consultant, Pharmacovigilance Licensing Department (4 m) – Home based.

    - Business Process Management Expert Consultant, Quality Management and Compliance Department (7m) – Belgium (Antwerp area/Home based).

    - Pharmacovigilance Licensing Consultant, Pharmacovigilance Licensing Department (18m) – Switzerland (Basel) / Home based.

    - Clinical QA GCP Consultant, Clinical Quality Assurance Department (13m) – Belgium (Antwerp area) / Home based.

    - Pharmacovigilance Agreements Consultant, Pharmacovigilance Compliance & Training Department (9m) – Germany (Bonn area) / Home based.

    - Quality Assurance Advisor GCLP Consultant, Quality Assurance & Systems R&D Department (6m) – Belgium (Brussels area).

    - Business Process Analyst/ Quality Documentation Writing Consultant, Clinical Quality and Continuous Improvement Department (3m) – France (Paris area).

    - Clinical Project Manager Consultant, Clinical Operations Europe Department (7m) – Belgium (Brussels).

  • GlaxoSmithKline Vaccines - Safety Business Operations Senior Manager

    Wavre 2009 - 2012

  • UCB - Global Pharmacovigilance Alliance Management, Associate-Director

    Braine l'Alleud 2007 - 2008

  • UCB Pharma - Clinical Trial Manager/Global Clinical Operations Manager

    Bruxelles 1998 - 2007

  • Merck Sharp Dohme - Associate Clinical Quality Assurance Auditor

    Bruxelles 1996 - 1998

  • PPD - Clinical Quality Assurance Auditor/Clinical Research Associate

    Bruxelles 1994 - 1996

  • Glaxo Belgium - Clinical Quality Assurance Scientist

    Bruxelles 1992 - 1994

Formations

  • Université Libre De Bruxelles (ULB) (Bruxelles)

    Bruxelles 1987 - 1991 Master in Criminological Sciences

    Legal / Process oriented degree (cf. understanding, review, analysis of regulations, standard operating procedures/processes, contracts with Investigator sites, CROs, Master Services Agreements, Service Level Agreements, Letters of Intent, Task Orders, Safety Data Exchange Agreements, etc.)
    To Date: Several courses, conferences, workshops in the areas of Good Pharmacovigilance Practices - Good Clinical Practices - Clinical Quality Assurance (RQA member) - Good Clinical Laboratory Practices - Clinical Project Management (PMBOK PMI) – Clinical Operations - Clinical Trial Monitoring - Outsourcing - Budget Forecasting/Management – Business Administration - Contract Management – Systems Audit – Standard Operating Procedures –– Lean Six Sigma – Risk Management - People Management – Data Protection.

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