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Experience

OCT 2018Present

Safety Operations Specialist -  Regulatory Reporting 

IQVIA

In training at the moment - Managing and  tracking queries and commitments with Regulatory Agencies, collaborates with subject matter experts to provide written responses to queries.

Tracking and delivery of project strategic plans including preparation of regulatory submissions, provide interpretation and guidance regarding  regulatory requirements for submission to Health Authorities - Regulatory Agencies. 

Supports regulatory activities regarding manufacture and distribution of  marketed products, OTC drugs, investigational products, and medical devices for the following markets: Canada, U.S. and LATAM. 

FEB 2017 OCT 2018

Data Analyst - Pharmacovigilance and case book-in associate.

Cognizant Technology Solutions

Captured timely and accurately, translated and performed case narrative of individual safety reports.

Managed tracking and follow up of adverse events reported in database according to company SOPs and local working practices, applying Risk Managements Plans and targeted Follow-ups questionnaires. Provided causality and seriousness assessment; medication, medical history and adverse events coding. 

Led data management and internal quality control assurance pre-routing to PharmaCentral. 

Conducted handling  of special case scenarios (overdose, abuse, misuse, medication error or occupational exposure, off label use, medicinal use in a pediatric or elderly population, LOE reports, technical complaints) and urgent safety issues (biological products, medical devices, pregnancy and breastfeeding cases).

Executed Local Health Authorities requirements. adherence to submission time frames in accordance to Local Working Practices and Health Authority guidelines.  

Acted as Back-up Team leader as required, leading Point of Contact with client and peers for daily activities and monthly clarification calls. Facilitated training, education and mentoring to new joiners and cross-cluster employees .

AUG 2015DEC 2016

Private Neonatal Nurse

Greenwich, Connecticut, U.S.

Private neonatal nurse, at-home care, lactation and sleep consultant, and family educator. 

OCT 2010AUG 2015

Neonatal Intensive Care Unit Nurse - On call Cath Lab Nurse.

SANATORIO MATER DEI

Level III NICU Nurse providing care to newborn premature and infant patients who required treatment at the Intensive and Intermediate Care Unit, Low risk Nursery, Delivery Room, Surgical Ward, Cath Lab, and Emergency Department. 

On-call Cath Lab Nurse, caring for adults, children and infants requiring emergency procedures. 

Acted as back-up Charge Nurse when required, managing teams up to 10 nurses. 

DEC 2009MAY 2010

Neonatal Intermediate Care Unit Nurse

SANATORIO DE LA TRINIDAD PALERMO

Nurse at the Intermediate Care Unit and Delivery Room. 

Education

20072011

Undergraduate Degree in Nursing Science - Lic. en Enfermería

UNIVERSIDAD AUSTRAL 

G.P.  8,5.

National licence Nr: 70.921. 

Certifications

  • Global Health Now, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH. May 2017.
  • Care and general procedures in Newborns, UNIVERSIDAD DE CHILE, May 2017.
  • Neonatal Resuscitation and CPR, certified by SOCIEDAD ARGENTINA DE PEDIATRÍA. 
  • Basic Life Support (BLS) using AED (Automated External Defibrillator), certified by AMERICAN HEART ASSOCIATION. 
  • Metodología de la Investigación y Monitoreo de Estudios Clínicos, UNIVERSIDAD AUSTRAL, 2017.