Ana L Figueroa ***** Old Blanco Rd Apt **** San Antonio, Texas 78216

Tel 847-***-**** c4i3nq@r.postjobfree.com

Summary of Qualifications

Three to four years of progressive responsible positions within the drug pharmacovigilance field.

Knowledge of International Conference on Harmonization (ICH) and Federal Drug Administration Regulations (FDA).

Adverse event reporting and management such as: imputing events into the safety database and Individual Case Safety Report of the patient's event which are composed and submitted to global regulatory agencies. The Individual Adverse Events are further analyzed on a regular basis to assess for changes in the benefit-risk profile of the medicinal product.

Core Activities for Adverse Event Reporting and Management: collection of adverse events and triage by trained specialists, thorough and accurate documentation of adverse event case data for - clinical studies, drugs, and biologics; case processing, including data entry, narrative generation, and quality-control; MedDRA Coding (including regular updates); follow-up information inquiries; MedWatch 3500A/CIOMS report generation; medical review, including MedDRA coding review, follow-up case processing and case closure. Proven proficiency in organizing all aspects of a medical/pharmaceutical research project.

By nature a self-motivated, creative thinker with the ability to create excellent interpersonal, analytical, and organizational skills. Ability to see opportunities and to set and achieve goals. Expert in communicating orally, in writing, or via electronic means, in an appropriate manner to the audience. Fluent in English and Spanish.

Work History

VIP Staffing San Antonio, TX May 2011-Dec 2011

Complaint Analyst

Temporary Responsible for analyses and control of complaints received from external customers with respect to business objectives and in compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR) and other regulatory guidelines

Facilitate all complaint investigation activities with cross functional team members and prepare complaint investigation reports

H & R Block Waukegan, IL 1/ 2011 – 4/2011

Customer Service Professional Part-time

Abbott Laboratories North Chicago, IL 1/2006 - Apr 2011

Medical Safety Analyst

Receive document, follow-up and close product complaints as reported from various sources.

Assess individual complaints for adverse event reporting requirements according to US FDA regulations for medical devices and drugs.

Ponce School of Medicine Ponce, Puerto Rico 7/2002 - 1/2006

Clinical Research Coordinator / Nurse Clinical

Research experience on Diabetes, Woman's Health, Osteoporosis, Cancer Prevention, Prostate, Hepatitis C, HIV, Anemia/Renal Failure, Hypertension, Vaccine Trials Rotavirus/Human Papilloma Virus, Neuroscience, Diabetic Neuropathy, Schizophrenia, Fibromyalgia, Erectile Dysfunction, Gene Therapy, Rheumatology, and others.

Worked under the direct supervision of a physician investigator.

Mennonite General Hospital, Inc Cayey, Puerto Rico 3/2000 - 07/2002

Emergency Room Nurse

Education

Interamerican University of Puerto Rico Guayama, Puerto Rico 1997

Bachelor's degree - Major: Nursing

GPA: 3.50 Semester Hours: 144 credit hours I had a significantly expanded scope of practice, education and clinical training in general nursing practices.

Additional Skills/Experience

Certifications College of Lake County - Grayslake, IL Certificate - Phlebotomy Technician (Mar - Jun 2007)

H & R Block - Tax Professional Certificate (2009)

College of Lake County Certificate - ServSafe: Food Service Sanitation (Mar 2011) Food safety training with the National Restaurant Association