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Drug Safety Data Entry

Location:
San Jose, CA
Posted:
February 15, 2024

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Resume:

SUSANNE CUEVAS

San Jose, CA *****408-***-**** • ad3nqp@r.postjobfree.com

Professional Summary

Tenacious and organized professional with 20 years of proven experience in driving efficiency and excellence throughout organizational functions. Maintains effective flow of communication between teams and senior leaders, as well as significant improvements to project management, internal systems, and team productivity. Research and processes data in a prompt and thoughtful manner. A reactive leader who is known to complete complex tasks promptly during emergencies that require a quick turnaround.

Skills

Analytical and critical thinking skills

Managing Adverse Events

Quality Monitoring

Travel Arrangement Scheduling

Customer Experience

Clinical Study Reports

Accurate Data Entry

Safety Procedures

Payroll Processing

Medical Terminology

Administrative Support

Client Correspondence

Work History

Drug Safety Associate I, 03/2019 to Current

CCS Associates – San Jose, CA

Receive and track SAE reports and supporting documentation in SAE tracking database.

Supply background information on earlier SAE reports to support evaluation by Drug Safety Physician or Drug Safety Associate

Coordinate and manage distribution of SAE reports and supporting documentation internally to Drug Safety Physicians and externally to sponsor, sites, and pharma partners.

Enter data into proper SAE database for specific study, including batch validation and discrepancy report generation.

Prepare AE/SAE reconciliations for sponsor and pharma partners.

Reviewed ancillary documentation to find information for processing and electronic capture.

Communicated with internal or external contacts to resolve issues related to case processing.

Skilled at working independently and collaboratively in a team environment.

Perform active follow-up and query management, including both written and verbal communication with healthcare professionals, medical monitors, and clinical sites.

Generate MedWatch, CIOMS II, and other standard listings from applicable safety databases.

Aid in projects for clients as requested by Drug Safety Operations Manager

Knowledge of statutes, regulations, and guidance's applicable to US and international serious adverse event reporting and regulatory affairs.

Managed time efficiently to complete all tasks within deadlines.

Preschool Receptionist, 10/2018 to 03/2019

Sunny Days Preschool – San Jose, CA

Collaborated closely with preschool teacher to achieve daily tasks.

Responded to parents' requests via telephone and email.

Kept the reception area clean and neat to give visitors a positive first impression.

Answered phone promptly and directed incoming calls to correct offices.

Maintained safety and security of all youth under care.

Greeted incoming visitors and customers professionally and supplied friendly, knowledgeable aid.

Maintained confidentiality of information about clients and company.

Supplied clerical support to company employees by copying, faxing, and filing documents.

Skilled at working independently and collaboratively in a team environment.

Strengthened communication skills through regular interactions with others.

Administrative Assistant, 10/2011 to 09/2018

Pediatric Therapy Services – San Jose, CA

Enter in school billing daily and email new patient packets.

Executed record filing system to improve document organization and management.

Restocked supplies and placed purchase orders to keep adequate stock levels.

Managed school billing.

Received and sorted incoming mail and packages to record, dispatch, or distribute to correct recipient.

Created and kept databases to track and record customer data.

Managed insurance billing for clients

Increased office participation in unique events by creating a newsletter with detailed calendars and other office updates.

Answered multi-line phone system, routing calls, delivering messages to staff, and greeting visitors.

Aided coworkers and staff members with special tasks daily.

Education

Associate of Arts: Liberal arts – Social Behaviors and Sciences

San Jose City College - San Jose, CA

High School Diploma: 08/1995

Santa Teresa High School - San Jose, CA

Certifications

Advanced MedDRA Coding - Certified

NIH Certificate - 2023 Information Security Management

NIH Certificate - 2023 Secure Remote Computing

BLS



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