I am working in pharmaceutical industry in the R&D and Corporate perimeters since 1993 and I have developed some expertizes and some knowledge, as:
-> International visibility.
-> Ability to fully understand, analyze and translate the business' requirements into processes due to a business and computing background.
-> Elaborate strategic plan of development and deployment in term of the enterprise service in partnership with Business and Information Solution.
-> Incube and Promote any innovation in term of in silico approaches. -> Ability to efficiently build networks, create and perpetuate partnerships.
-> Extensive experience in needs assessment, curriculum development, planning and development, policies and procedures, budgeting and program management.
->Ability to successfully manage multiple priorities and assignments.
->Proven capacity to approach problems effectively and creatively.
->Strong leader with motivational management style and reputation for building and retaining highly motivated team members.
- Business development, Enterprise service at high value added, Cross industry innovation analysis.
- Outsourcing solution implementation, Resources' management.
- Business & Competitive Intelligence, Information Management, Knowlegde Mangement, Communities Management, Information System, Collaborative plateform, etc.
Head of Safety & Regulatory Information Systems and Management Antony, France
Since September 2016
-> Define, prepare, implement and operate the strategic plan of Safety & Regulatory Information System
-> Develop and improve the environment of the data management and mining tools; Extract, edit and benchmark the Pharmacovigilance & Regulatory Affairs management tools (KPIs); Contribute to the Safety & Regulatory Quality plan
-> Develop the Safety & Regulatory Information System and manage the interface of Safety & Regulatory Information System with the other enterprise data owners (GMA, GCD, Market Studies, Manufacturing)
- Team management;
- Manage the external providers (offshore & nearshore);
- Pilot the transversal enterprise project (EMA ISO IDMP project); Coordonate the cross functional activities (labeling committee);
- Stand for the Business at the Policy and Regulatory Intelligence function, watch focus in the new technologies (social network, Google).
Senior Expert, Member representing EBE in IDMP Group @ EMA London, United Kingdom
Since March 2015
- Define common principles for the ISO IDMP implementation in the EU;
- Approve the operating data model for data exchange;
- Develop and implement an EU ISO IDMP Road Map.
Expert in Big data | Smart data group Paris, France
Since November 2014
Big Data ideation: generate ideas / mixed and complex uses; Annual recommendations on the state investments’ orientation; Reflections on Privacy / Quantified Self / Blue Button / my data for science; Regulations on data protection and process @ -health; Interoperability of sectors in institutional and personal data materials resources; Production of use cases and of public awareness tools production of use cases and public awareness tools (internal and external to enterprises); Produce a White Paper and educational infographics (mapping data).
Member of the knowledge committee Paris, France
Since May 2013
Cap Digital is today recognized as one of the major European clusters dedicated to the digital creative industries. European and international collaborations were one of the main initial objectives of the cluster.
Head of Safety Data Governance in Pharmacovigilance Antony, France
October 2015 --- September 2016
->Define, prepare, implement and operate the strategic plan of Safety Information System
->Data gourvenance for the Safety Data:
- Develop and improve the environment of the data management and mining tools
- Validate the safety data extraction to populate the safety reports (PSUR, AMM, AMM renewal)
- Extract, edit and benchmark the Corporate Pharmacovigilance management tools (KPIs)
- Contribute to the Safety Quality plan in close collaboration with the other unit of Corporate Pharmacovigilance fonction
->Contribute to the development of Safety Information System and manage the interface of Safety Information System with the other enterprise data as GMA, RA, GCD, Market Studies and Pharmacovigilance training.
- Team management
- Management of external provider of the Phamacovigilance activities (offshore)
- Pilot the transversal enterprise project (EMA ISO IDMP project)
- Stand for the Business at the Policy and Regulatory Intelligence function, watch focus in the new technologies (social network, Google) impacted in the Pharmacovigilance.
Head of Compliance and Data Management in Corporate Pharmacovigilance Antony, France
July 2013 --- October 2015
- International Pharmacovigilance network management – subsidiary support, regulatory documents, safety information, training of company salaries, partners and contractors;
- Development, deployment and exploitation of Global Pharmacovigilance information platform – System owner;
- Accountable of the Corporate Pharmacovigilance Standard Operating Procedures (SOPs) and reference documents – Owner;
- Definition, development, editing, analysis and management of Corporate Pharmacovigilance unit activities dashboard – activities indicators, KPIs, resources management, regulatory documentation planning;
- Surety of data capture, of data management, of data mining, of data extraction and of data Quality Control – populate the regulatory periodic report (PSURs, DSUR, signal detection);
- Team management (4 collaborators).
Scientific Information & Intelligence in R&D Paris, France
September 2012 --- June 2013
- Design, development and deployment of Scientific information and/or Knowledge intelligence platform;
- Scientific communities management;
- Promotion & communication of strategic scientific platform.
R&D Information Solution Massy, France
March 2010 --- September 2012
- Interact and advise the Transverse service solution, the Information Solution teams and Business "clients" as a senior expert in Search Engines, Data / Text Mining Technologies, Data / Information / Knowledge Management, Competitive Intelligence, Communities Management, Collaborative Tools, Outsourcing solution;
- Elaborate strategic plan of development and deployment in term of the enterprise service in partnership with Business and the solution director of Information Solution;
- Incube and Promote any innovation in term of in silico approaches thanks the Committee of Practice in R&D Information Solution
SCDM head Vitry-sur-Seine, France
January 2005 --- March 2010
Head of Scientific Computing & Data Management Dtp (SCDM) in the Paris Region (4 research sites) & SC activity in France (7 research sites), Manage a 40 people team in the Discovery Research:
-Manage the team adapting / developing the tools and particular solutions fitting with research departments’ requirements & the team developing, improving / maintaining the in-silico work environment for the in-silico teams of the Discovery Research;
-Elaborate synergic strategy of development for the fundation system in patnership with SIS / IT functions;
-Popularize SCDM approach for the researcher community: internal & academic training or conferences;
-Manage the current budget (2 M€) & plan the future financial plan supporting the future needs of the research departments;
-SCDM activities’ consolidation in France thanks to the implemantation of the hiring plan for the next 3 year;
-Participate in the global strategy definition in the “SCDM operational committee”.
-Valuation of the information (Search and Browsing/Navigation, survey) and Collaboration / management of contents (Dematerialization, Collaboration, Management of documents)
-Access to the information (Search engine of company, text mining, classification, creation and management of taxonomies, extraction of entities, navigation, display of information, etc.), Electronic document management and Automatic Reading of Documents, Content management, Workflow and BPM, synchronous and asynchronous Collaboration, Portal.
Head of Bioinformatics France Vitry-sur-Seine, France
November 2002 --- December 2004
formerly Group Leader (10/2002-09/2003), Manage a 11 people team plus 10 external contractors and students in the Drug Innovation & Approval department,
->Manage the team adapting or developing the tools and particular solutions fitting with disease groups’ requirements;
->Elaborate synergic strategy of development for the integration of a global platform gathering Chemo and Bioinformatics;
->Popularize Bioinformatics approach for the end users through the internal and academic training or conferences;
->Manage the current budget (1.2 M€) and plan the future financial plan supporting the future needs of the disease groups and of their functional support groups;
->Hire 4 more people to consolidate the team, aiming at completing the global bioinformatics skills of the group in the current six months period;
->Participate in the global strategy definition in the “Bioinformatics Management Team”.
Project Manager Vitry-sur-Seine, France
November 2001 --- October 2002
In charge of the bioinformatics research projects elaboration and management for the support of the disease groups (Oncology, Neurodegenerative and Infectious) and the validation of bioinformatics approach of their functional support groups
Pharmacology Research Assistant Croissy-sur-Seine, France
September 1993 --- October 2001
Responsible for ADN automatic sequencer lab and Analytical Bioinformatics,
->Managed the whole setting up of a sequencing laboratory (Perkin Elmer 377) e.g.: choice and purchasing of the machines, laboratory configuration and optimisation, complete process elaboration; -
>Participated in the initiation and progress of biological and bioinformatics research programs.
AdaptabilityAnalytical thinkingAuthenticityCharmCollaborationCommunicativeCompetitivenessCreative thinkingCritical thinkingCuriosityDependabilityEfficiencyEmotional reactivityFlexibilityInnovative thinkingInterest in knowledgeOptimismPerspectiveProactivityProblem solvingResponsibilityResult OrientedSelf-disciplineSelf-confidenceService orientedStrategic thinkingSociabilityTrustWillingness to compromiseStriving
Skills and Expertise
Manage multiple projectsData mining Analytical skills Analyze dataEnsure data consistencyDesign data reporting systemsDesign IT solutionsWork with coordination and data management teams Interpret data Molecular DiagnosticsCreates a collaborative team environmentLead teamsNegotiate budget Monitoring subject complianceRegulatory submissionsAnalyze data/information to determine potential relationships. Create SOPs Design case record forms Report dataAdvise on strategyApprove monitoring reportsAttend steering committeeCollaborate with medical teamcollaborate in research projects at universitiesCollaborate with project teamCollect dataCommunicationCommunicate with sponsorConduct literature searchesCreate standard operating procedure (SOP)Data codingData validationData verificationData entryDesign database Develop business plan
master in Molecular & cellular Biology from École Pratique des Hautes Études in 1998
Training and Certification
Conflict Negotiation in 2004 Training
Executive Development - Team Management, HEC in 2004 Training
Team Management training in 2003 Training
KOALA-T Management Process in 2002 Training
University certification in Bioinformatic in 2000 Certification
Expert has 7 publications (Will be avalible with full profile)