Ashley Ruelas

Experience

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  UC San Diego

  May 2016 - Jun 2018

  Student Involvement Leadership Consultant

  - Developed customer service skills by assisting with event space reservations via Event Management System Enterprise (EMS).- The first point of contact for student leaders and departments who need assistance with event planning, funding, and campus involvement opportunities.- Managed 15+ administrative calendars via Microsoft Outlook.- Coordinated logistics, problem-solved and created graphic designs for campus–wide events.- Oversaw daily event audits and executed quarterly smart goals. Show less

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  Kaiser Permanente

  Jul 2017 - Sept 2017

  Administration Intern

  - Coordinated Safety Fair, conducted Life Care Planning research, and supported facility operations.- Revised educational tools for physicians and took minutes for all manager and service area director meetings.- Inputted data of 100+ Life Care Planning forms into KP HealthConnect® – private electronic health record system.

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  Google

  Sept 2018 - Jan 2019

  Recruiting Coordinator

  - Supported staffing efforts for technical (software engineer) roles by scheduling 200+ interviews per week, organizing travel arrangements, and facilitating special accommodations. - Ensured candidate experience by troubleshooting technical difficulties and resolving last minute conflicts.- Managed employment-related correspondence (applications and non-disclosure agreements), while maintaining data integrity and confidentiality at all times.

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  Gilead Sciences

  Jan 2019 - Feb 2021

  - Performed detailed assessment and QC of ICSR submissions, including SUSARs, originating from post marketing and clinical trial sources. Assessed reportability to regulatory authorities, ethic committees and principal investigators, with up to 15+ reportable destinations per case. - Communicated directly with internal departments (i.e. Global Patient Safety, Clinical Operations, etc) and various groups (i.e. license partners, health authorities) to meet compliance.- Monitored and triaged shared team inbox, as well as configure Outlook email rules for the team.- Monitored E2B reports for failures and pending ACKs.- Tracked and submitted Missing Informed Dates (MIDs) for ICSRs submitted via CIOMS-I and MedWatch.- Contributor for various projects: Entered data for new global regulatory reporting requirements tool. Completed internal audit for ICSRs submitted to a specific destination. Show less - Optimized safety surveillance protocols by meticulously reviewing and entering adverse event data into Argus, covering a wide range of investigational and post-marketing products.- Queried for missing information, performed follow up after book in and assisted with multiple bulk projects.- Ensured accurate data entry conventions and correct event terms were properly entered based on MedDRA coding.- Developed and executed impactful team building initiatives in collaboration with management. Show less

  • Drug Safety Specialist (Submissions)

    Oct 2019 - Feb 2021

  • Drug Safety Specialist (Intake)

    Jan 2019 - Oct 2019
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  IQVIA

  Feb 2021 - Jan 2023

  Regulatory Reporting Operations Specialist

  - Submitted and assessed clinical and post marketed product data to regulatory authorities and oversight groups via email and Argus (CIOMS-I and E2B).- Performed QC checks for peer reportablity assessments and submissions.- Ensured accurate filing and precise QC of eTMF (electronic trial master file) documents.- Executed periodic reports, including 6 monthly(PSUR) and annual reports(DSUR).- Trained and liaised with global IQVIA offices to facilitate expedited reporting and understanding of project deliverables. Show less

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  Cerus

  Jan 2023 - Jun 2023

  Global Product Safety Specialist 2

  - Managed case processing activities for clinical and post-marketed medical device reports specializing in pathogen-protected blood components.- Performed MedDRA coding and comprehensive narrative writing in Argus for SAEs and AEs.- Led project initiatives to organize and improve workflow, including the creation of a Microsoft Power BI dashboard.

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  Google

  Mar 2024 - now

  Program Manager

  Supporting Made for Google via ERG