Pierre-Olivier FERRY

En résumé

Entreprises

• Astellas Pharma - Senior Manager, Pharmacovigilance Information Management Technology Development

  Levallois-Perret 2014 - maintenant Responsibility
  • Mid and Long term GPV IT systems strategy
  • GPV IT System roadmaps
  • Global Signal Management Project Lead / GPV IDMP Project Management
  Delivery
  • Project plans and budgets for all GPV IT projects.
  • GPV Information strategy
  • Networking with internal and external partners to deliver PV systems.
  • Identification and implementation of innovations and advances in PV IM.
  • Empirica Projects Lead.
  • IDMP PV Project Management.

• Astellas Pharma Europe - Senior Manager, Safety Information Management

  2011 - 2014 Responsibility
  Project Management of PV Register
  Safety Signal and Evaluation Team member
  Delivery
  The key objectives of the project were to gain consistency among all affiliates in case tracking and report submission to authorities, standardized reporting and secured data storage.
  • Creation of CSV and Project related documents:
  PB, PID, URS, GxP assessment, Data Migration Protocol, OPQ, Decommissioning Plan, BCP, Maintenance Manual, Training Plan, Post Production Test, Post Implementation Review.
  • 154 Users Training Creation/Delivery
  • Support first phase Implementation in 53 Countries : Europe/Asia/Oceania/Africa
  • Next version: URS ongoing
  
  Support ASSET (Astellas Safety Signal and Evaluation Tool) that will aid in signal detection, prioritization and evaluation activities. The Empirica Signal™ software provide access to external adverse event databases (FDA AERS, WHO Vigibase) and the internal Astellas proprietary safety database (Argus).

• Eli Lilly - Pharmacovigilance Data System Analyst

  neuilly sur seine 2007 - 2011 Responsibility
  • Green Belt Lean Six Sigma
  • Global Patient Safety Data System Analyst (GPS DSA)
  Delivery
  • 2010-2011 - Six Sigma project : Management and Control of safety agreement in our contracts, coordination and training of the various stakeholders like Pharmacovigilance, legal, regulatory affairs, purchases and clinical.
  • 2008-2011 - Recurring preparation and project improvement of Pharmacovigilance data, to produce before, during and after the inspections and audits to the Japan, in Europe, the Middle East and America.
  Major Inspections supported :
  o U.S. Health Agency (FDA) August 2010.
  o French Agency AFSSAPS in french affiliate July 2010.
  o French Agency AFSSAPS in Fegersheim manufactory February 2010.
  o British health agency MHRA May 2009.
  • 2007-2011 – Management of the Internal Audit of Pharmacovigilance Lilly project :
  o Reports prework (SAS, BO, ACCESS, Argus Insight).
  o Target of audits: partners and service providers.
  • 2008-2011 – Project Intranet Pharmacovigilance information request :
  o Creation and management of Pharmacovigilance data request interface (BO, SAS, Power Report).
  • 2007-2011 – Followup letters project :
  o Implementation and monitoring of developments in the management of followup letters to the France affiliate.
  • 2007-2008 – Intensive monitoring reports project :
  o Creation and validation under SAS and BusinessObjects report of intensive monitoring reports for certain drugs in CIOMS II Line listing and Summary tab format.
  o Developments and validation of the reports following AFSSAPS French Agency new requirements.
  • 2008 – Project support monitoring Oncology drugs:
  o User requirements creation by taking into account business needs and functional specification needs.
  o Creation of standard reports.
  o Training and certification for the use of the reports.

• Eli Lilly - Pharmacovigilance Operations

  neuilly sur seine 2002 - 2006 Responsibility
  • Global Pharmacovigilance database admin.
  • Representative of Lilly for the implementation of the electronic submission of spontaneous cases (ICH E2B) to the European Agency for the drug (EMEA).
  • Global and local Pharmacovigilance project management
  • Involvement in the redesign of the Pharmacovigilance company tool project.
  • Driver of change: definition and implementation of the new organization of Pharmacovigilance.
  
  Delivery
  • Case Quality Metrics dashboard for Core Sites in Q1 2006
  • 2006 – Core sites Pharmacovigilance data consolidation project :
  o Monthly dashboard “Case Quality Metrics” (SAS).
  • 2005 –Validation of the Argus BusinessObjects universe Project:
  o Users agreement for more than 150 Argus Power Reports (Argus Insight).
  • 2004 – Project Training and Support in Pharmacovigilance, integration of 10 new incoming countries in the enlargement of the European union :
  o Synthesis of the regulatory obligations of the European Community.
  o Training in Pharmacovigilance European requirements.
  o Organization and animation of a meeting in Vienna (Austria).
  • 2003-2004 – Project implementation of the new Lilly Pharmacovigilance system:
  o Drafting of the specifications.
  o Provider selection.
  o Configuration and installation of the new system of Pharmacovigilance from the company.
  o Implementation of the new world Organization, training and support.
  • 2002-2004 – Project European Electronic Adverse Event Submission:
  o Participation in the European Agency (EMEA) in London, to the practical application of the ICH E2B standard for the electronic submission of spontaneous side effects.
  o Configuration and implementation of this standard in the new system of Pharmacovigilance from the company.
  • 2003 – French Pharmacovigilance Core Site project :
  o Management and coordination of the technical and organizational project phases.

• Eli Lilly - IT European Regulatory, Clinical Operation, Pharmacovigilance applications support

  neuilly sur seine 2000 - 2002 • 2000-2002 – Creation of the position of Medical IT Business Integrator:
  o Management of Regulatory Affairs, Clinical operation, Documentation medical and Pharmacovigilance applications for Europe.
  o European IT group involvement.

• Aventis - IT Project Manager

  Paris 1999 - 2000 • Managed PhV’s systems merge project.

• Rhone-Poulenc-Rorer - IT Project Leader

  1995 - 1998 • Development, Implementation, Support Pharmacovigilance’s system.

• ACOMIS - IT Analyst

  1989 - 1994

• CETELEM - IT System Analyst

  1986 - 1988

Formations

Réseau

• Ala FAKHFAKH

• Cristina BODIOT

• Feriel NOURI

• Gaelle BOESMANS

• Guillaume JOUARDET

• Isabelle TETE

• Noel COQUIO

• Olivier BOUSSEKEY

• Sophie CHANIER

• Yasmina HAMIMI

  Softeam Group (Ivry-sur-Seine)