Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Drug Safety Associate I
CCS Associates
03.2019 - Current
Receive and track SAE reports and supporting documentation in SAE tracking database
Provide background information on previous 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 appropriate 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 identify 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 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
Assist 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.
Worked well in team setting, providing support and guidance.
Managed time efficiently in order to complete all tasks within deadlines.
Preschool Receptionist
Sunny Days Preschool
10.2018 - 03.2019
Worked closely with preschool teacher to achieve daily tasks
Responded to parents’ requests via telephone and email
Kept reception area clean and neat to give visitors 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 provided friendly, knowledgeable assistance.
Maintained confidentiality of information regarding clients and company.
Provided clerical support to company employees by copying, faxing, and filing documents.
Skilled at working independently and collaboratively in team environment.
Proven ability to learn quickly and adapt to new situations.
Strengthened communication skills through regular interactions with others.
Administrative Assistant
Pediatric Therapy Services
10.2011 - 09.2018
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 maintain adequate stock levels.
Handled school billing
Received and sorted incoming mail and packages to record, dispatch, or distribute to correct recipient.
Created and maintained databases to track and record customer data.
Managed insurance billing for clients
Increased office participation in special events by creating newsletter with detailed calendars and other office updates.
Answered multi-line phone system, routing calls, delivering messages to staff and greeting visitors.
Assisted coworkers and staff members with special tasks on daily basis.
Education
Associate of Arts - Liberal arts – Social Behaviors and Sciences
San Jose City College
San Jose, CA
05.2024
High School Diploma -
Santa Teresa High School
San Jose, CA
08.1995
Skills
Meeting Support
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
Certification
Advanced MedDRA Coding - Certified
NIH Certificate - 2023 Information Security Management
NIH Certificate - 2023 Secure Remote Computing
Timeline
Drug Safety Associate I
CCS Associates
03.2019 - Current
Preschool Receptionist
Sunny Days Preschool
10.2018 - 03.2019
Administrative Assistant
Pediatric Therapy Services
10.2011 - 09.2018
Associate of Arts - Liberal arts – Social Behaviors and Sciences