I would describe myself as being polyvalent and savvy; I enjoy a challenge and problem solving and I most enjoy working in an environment with like-minded ambitious people in an environment with freedom to grow and learn. Specialties: EVWEB, xEVMPD, IDMP, Global Regulatory Affairs, Clinical Research, Oncology, Late Phase Clinical Trials, ICH, GCP, Validation Reporting/Testing, End user support, Medication Allocation, Remote Site support, Pharmacovigilance, Liquent,ePRO
Regulatory Affairs Consultant to MSD-Merck
Since August 2014
XEVMPD and IDMP implementation: The primary objective of XEVMPD / IDMP is to unambiguously identify medicinal products and active substances reported in ICSRs when loaded in EudraVigilance, the Pharmacovigilance system of the EMA.
Regulatory Affairs Consultant to UCB Pharma
April 2012 --- December 2013
Global Regulatory Affairs Consultant to UCB Pharma, concerning Implementation of Article 57(2) “Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorisation Holders to the European Medicine Agency”- EVWEB and XEVMPD coordination. Global CTA document administration, audit readiness collection activities and coordination of database of files.
Randomization Team/Client Support Specialist
January 2010 --- January 2012
Administration of Global Clinical Databases, providing End User and Site staff Support, training of staff, Validation of Clinical software and testing, Data Coordination
Clinical Research Associate (CRA)
January 2008 --- January 2009
Oversaw Clinical Trials sites in two separate global regions for a global study involving HIV patients and comparator drugs results. Oncology studies featuring Pregnancies, assessing the possible serious/adverse effects of drug exposures. AntiretroViral Therapies concluded throughout a pregnancy.
Senior Certified Pharmacy Technician
January 2007 --- January 2008
Working under the direct supervision of a licensed pharmacist, I performed the many pharmacy related functions expected for a smooth running business. Duties include providing medication and other health care products to patients, preparing prescribed medication and providing drugs to patients. Inventory management and Rx supervision.
Assistant to the Secretary General and Departments of Banking Supervision et al.
January 2007 --- January 2007
Fast Paced Position involving varied time-sensitive daily tasks; including record keeping, KPI reporting, and data entry to the internal/external databases of member countries and banking federations spanning the European sector.
Patient/Therapist Administrative Coordinator
June 2004 --- December 2006
Contacting individual service providers throughout several Southwest/Central Florida counties, using templates to coordinate and ensure deadlines were met for therapists reporting, patient evaluations and timesheets Update of payroll records using MS Access database software for “Therapists personal data system” Cross-checked reported hours worked with hours paid using MS Excel, sent reminders to staff if necessary
Client/Patient Service Coordinator
October 2001 --- June 2004
Creation and maintenance of reports analyzing client profiles regarding outstanding balances; contacting those and ensuring timely repayment for services rendered Expedited and coordinated surgery schedules and appointments , cross referencing current schedules to maximize efficiency Extensive data entry, responsibilities included regular update of doctor/patient entries, follow up calls and correspondence with clients and Doctors
Skills and Expertise
Create SOPs Guide students Interpret data Report data Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdministrative supportApprove drug supply Attend seminars, courses and meetings within and outside the companyCapture data on source documentsCoach staff
Certification in Certificate of Completion for Basics of European Regulatory Affairs from TOPRA The Organisation for Professionals in Regulatory Affairs in 2014
Sharepoint course certification in Microsoft Sharepoint for Power Users 2010/2013 from Sharepoint 2010 Training in 2014
in French from A.P. Leto Comprehensive High School in 2002
Training and Certification
'Microsoft Sharepoint 2010' training Certification Certification