Marta CARNIELLI

En résumé

Entreprises

• Ortho Clinical Diagnostics - Manager II

  2014 - maintenant II, Safety Risk Management & Surveillance & QRC at Ortho-Clinical Diagnostics, Same responsibilities as Safety Risk Management & Surveillance
  Executive Management Representative-Quality Lead for the Illkirch site
  Supervision of the Quality Regulatory and Compliance Supply Chain team

• Ortho Clinical Diagnostics - Manager II

  2011 - 2014 II, Safety Risk Management & Surveillance at Ortho-Clinical Diagnostics,
  Provide leadership and guidance to the SRM&S teams based in Illkirch, Pencoed (UK) and Raritan (NJ)
  Responsible for Vigilance Reporting activities in the EEA ; chairman of EDMA Vigilance Task Force (
  Responsible for Complaint Handling processes related to WW Transfusion Medicine and Pharmacovigilance
  RhoGAM EEA Qualified Person for Pharmacovigilance
  Supports Audits conducted by Global regulatory agencies
  Perform supplier audits
  Provide presentations at external conferences on Post Market Surveillance and Vigilance topics
  chairman of EDMA Vigilance Task Force (since November 2012)

• Ortho Clinical Diagnostics - Senior Manager

  2011 - maintenant

• Ortho Clinical Diagnostics - Manager

  2010 - 2011 I, Safety Risk Management & Surveillance at Ortho-Clinical Diagnostics,
  Provide leadership and guidance to the SRM&S team based in Illkirch and Pencoed
  Responsible for Vigilance Reporting activities in the EEA; organized transfer of Vigilance responsibilities from Regulatory Affairs to the SRM&S team
  RhoGAM EEA Qualified Person for Pharmacovigilance

• Ortho Clinical Diagnostics - Manager Product Vigilance and QRC International

  2008 - 2010 Provide leadership and guidance to the Product Vigilance team based in Strasbourg and Pencoed and to the Quality Supply Chain team
  RhoGAM EEA Qualified Person for Pharmacovigilance

• Ortho-Clinical Diagnostics - Supervisor , International Complaint Unit

  2005 - 2008 Provide leadership and guidance to the International Complaint Handling Unit team
  Ensures that all customer complaints are evaluated, investigated, and documented as appropriate
  RhoGAM EEA Qualified Person for Pharmacovigilance

• Ortho-Clinical Diagnostics - Senior Customer Quality Investigator

  2002 - 2005 Investigate unresolved Immunodiagnostics reagent and system complaints to root cause
  Assess adverse events for potential reportability to US and International competent authorities.
  Participate to internal and external audits
  RhoGAM EEA Qualified Person for Pharmacovigilance Deputy

• Ortho-Clinical Diagnostics - Senior International Scientific Support Specialist

  1996 - 2002 Provide technical support and training to field personnel throughout the EMEA and ASPAC region for all Vitros chemistry and immunodiagnostics systems

• Ortho-Clinical Diagnostics - Customer Support Specialist

  1995 - 1996 First Level Support to Italian customers for Clinical Chemistry equipments

• Rijksuniversiteit Leiden - Laboratory Technician

  1994 - 1995 Techniques used: HLPC, GC

• Ospedale di Cattinara - Internship

  1993 - 1993 Internship at the Pharmacy of the Hospital, Ospedale di Cattinara-Trieste- Italy

Formations

• AFNOR COMPETENCES

  Paris 2008 - 2008 IRCA

• ULP (Université Louis Pasteur)

  Strasbourg 2004 - 2007 DIU
  
  Diplôme de Formation des Investigateur aux, University Louis Pasteur,

• Università Degli Studi Di TRIESTE (Trieste)

  Trieste 1993 - 1993 DEA Pharmacie-Option Officine
  
  Master Degree110 marks out of 110. Passed with honours

• Università Degli Studi Di TRIESTE (Trieste)

  Trieste 1987 - 1992 DEA Pharmacie Option Industrie
  
  Master Degree in Pharmacy-Università degli Studi di Trieste (Italy)
  110 marks out of 110. Passed with honours

• Università Degli Studi (Trieste)

  Trieste 1987 - 1993

Réseau

• Didier TREGOUET

• Ernesto PAISER

• Etienne PAUVERT

• Gérard VAN KLAVEREN

• Jean-Michel BERSCHEID

• Jean-Pierre MILONNET

• Natalia DE MOURA

• Ophélie LEBRETON

• Paulo RAMOS

• Valerie REIBEL