Cindy Parra
Valley Village,CA
Summary
Highly experienced Foreign Registered Nurse and Data Specialist with a decade-long career spanning the health, pharmaceutical, and educational sectors. Proficient in data management, medical writing, and regulatory compliance, with a proven track record of handling adverse events reporting and safety data analysis. Adept at cross-functional collaboration and maintaining high standards of data integrity and safety. Bilingual in English and Spanish, offering exceptional communication skills and a strong commitment to teamwork.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Safety Data Specialist (SSDS)
Merck Sharp & Dohme
Bogota, DC
11.2020 - 09.2021
- Managed adverse events reports ensuring high quality and compliance with global safety standards for both investigational and marketed products.
- Conducted detailed analysis and interpretation of adverse events from various sources, including literature and clinical studies.
- Maintained up-to-date knowledge of global regulations, guidelines, and standard operating procedures, enhancing database search efficiency and data entry accuracy.
- Review processed and void cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
- Consolidate cases according to regulatory requirements.
- Support business processes which are important to GPVCM operations and works closely with other staff within the organization as well cross-functionally.
- Review, rank, verify, process and document case-related information.
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, standard operating procedures, for data entry conventions, and for search functions in the safety database.
- Determine reportability of schedule reports, ensuring adherence to regulatory requirements.
Safety Data Specialist (SDS)
Merck Sharp & Dohme
Bogota, Colombia
03.2017 - 10.2020
- Responsible for processing adverse events (AE) information in the global safety system for investigational and / or marketed products, under the directions and supervision of a GPVCM Manager.
- Perform triage, analysis and interpretation of AE data following the Company Standard Operating Procedures (SOPs) and guidelines.
- Had a clear perception of case management processes, adhere to corporate policies and follow the company's ways of working, including leadership behaviors.
Caregiver
In Home Support Services
West Covina, CA
01.2014 - 07.2015
- Integrated care for elderly population.
- Nutrition, die and physical activity management.
- Education on healthy practices.
- Support in activities of daily living.
Practice Coordinator
Politécnico internacional
Bogota, DC
02.2011 - 12.2014
- Creation and implementation of the model for the evaluation of the teaching-service relationship of the professional Nursing Technical program.
- Maintenance of the teaching -service relationship between the training and provider institution.
- Coordination of meetings and documentation review.
- Management of academic and disciplinary situations of students during practices.
- Management in the development of institutional agreements for internships and practices.
- Development of schedules and students according to the capacity of each practice site.
- Coordination of teachers.
Education
Specialist in Curriculum And Pedagogy
University of The Andes
Bogotá, Colombia09-2011
Bachelor of Science in Nursing
University of Enviromental And Applied Sciences
Bogotá, Colombia12-2009
Skills
- Data management
- Medical writing
- Regulatory Compliance
- Pharmacovigilance
- Bilingual Communication
- Microsoft Office proficiency
- Effective Communication
- Adaptability
- Team building
- Analytical Skills
- Problem-solving aptitude
- Written Communication
- Organizational Skills
Languages
Spanish
Native/ Bilingual
English
Professional
Certification
- International Education Research Foundation, INC. Equivalency report- Bachelor of Science in Nursing.
Timeline
Senior Safety Data Specialist (SSDS)
Merck Sharp & Dohme
11.2020 - 09.2021
Safety Data Specialist (SDS)
Merck Sharp & Dohme
03.2017 - 10.2020
Caregiver
In Home Support Services
01.2014 - 07.2015
Practice Coordinator
Politécnico internacional
02.2011 - 12.2014
Specialist in Curriculum And Pedagogy
University of The Andes
Bachelor of Science in Nursing
University of Enviromental And Applied Sciences
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