Regulatory Affairs Coordinator
Since June 2014
- Assist the responsible of the Regulatory Affairs Department in the statutory follow-up of the requests of License of Launch on market of the specialities of the company - Prepare all the documents necessary for the renewal of the Licenses of Launch on market ( AMM)
October 2013 --- February 2014
Junior CRA - ESDS (Clinical Research)
May 2012 --- March 2013
- Project support of phase I Clinical Pharmacology / experimental medicine / novel biologics studies - Support regulatory submissions - Study initiation - Study conduct and observational monitoring - Clinical Data monitoring
Quality and Compliance Coordinator
January 2011 --- January 2012
-Provide full support for ensuring global quality and compliance Pharmacovigilance activities. -Provide GCSP Management with clear visibility of overall progress of projects and action plans, highlighting potential issues for resolution. -Collaborate with GCSP QA to guarantee compliance of the global Pharmacovigilance quality system with the corporate quality standards and to identify (recurrent) audit/inspection findings -Participate actively to the resolution of CAPAs -Provide data for the monthly compliance reports on safety activities -Escalate relevant Quality and/or Compliance issues when required.
Clinical Safety Associate
May 2011 --- September 2011
- Triaging, collecting, monitoring, processing, and distributing the adverse event reports (serious and non-serious Adverse Event(s) ) to sponsor or regulatory authorities and project team within specified timelines - Generate queries related to serious and non-serious Adverse Event and follow up until resolution. - Perform all safety database required functions, e.g data entry, narrative preparation, dictionary management etc, until completion of the case, and retrieve all customized and other regulatory reports. - Perform comparative review of Clinical and Safety database and reconciliation of all adverse events. - Perform other safety-related tasks that may be required for specific protocol or due to change in regulatory requirements.
Clinical Trials Assistant and CRA
May 2000 --- October 2010
- Support project team in all administrative activities. - Generate and maintain databases for appropriate administration. - Prepare and keep the master file and study centre files including all GCP-related documents. - Administer all study and related documents before and during the course of the study (i.e. drug accounting documents, correspondence, monitoring reports, contact reports, and other organizational papers). - Support Project Manager and CRAs in all relevant activities. - Transmit all CRFs after of the quality control procedures and registration in the CRF retrieval database to data management department for data entry and quality control. - Assist Project Manager in preparing project status reports for clients. - Submit final monitoring trip reports to the Regulatory Department for filing. - Assist Project Manager as required to ensure the successful completion of the study. - Assistance/support for the logistics aspects. - Document management and administrative support.
June 1997 --- May 1998
AdaptabilityAttention to detailCollaborationCommunicativeCoordinationCuriosityEfficiencyFlexibilityIndependenceOrganizationProactivityResult OrientedResponsibility
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