Jessica Kue-Yan
San Lorenzo,California
Summary
Dedicated professional with proven performance in vendor oversight, leadership, audit and inspection readiness, and workflow prioritization. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Stays calm under pressure.
Overview
8
8
years of professional experience
34
34
years of post-secondary education
Work History
Vendor Strategy Lead
Genentech
9 2023 - Current
- Vendor Strategy Lead Flow to cover Eversana Intouch Social media monitoring vendor, TransPerfect translation vendor and Ashfield AE intake vendor from July 2022- Aug 2023
- Collaborate with business/functional units to influence the design of PV Vendor processes ensuring adequate collection and processing of safety data and their timely reporting to the safety unit as per scope
- Identify risks and gaps for oversight of GVP Vendor
- Developed strategic oversight plan for ensuring PV compliance for GVP Vendors, including risk mitigation strategies
- Prepared a Service Provider Oversight Plan, illustrating joint ownership of vendor oversight shared between the US PS, Digital Customer Engagement and Listening Activities team, and Experience Operations team
- Prepared a Service Provider Oversight Plan, illustrating joint ownership of vendor oversight shared between the US PS and Global Procurement for contracts owned outside of US PS
- Devise and evaluate methods for collecting performance measurements, such as KPI of vendor missed identification of AEs, SS, and PCs
- Develop and implement communication and escalation pathways for vendor oversight to drive the desired state of collaboration and compliance
- Provide regular updates, and mitigation recommendations and escalate issues to US PS Leadership and Stakeholders
- Continuously monitors feedback to inform quality improvements and updates
- Act as Pharmacovigilance subject matter expert for GVP vendor processes in the event of audits or regulatory inspections
- Use appropriate metrics and quality checks to gain sufficient oversight of the GVP vendor processes and its effectiveness, aiming to achieve a desired state of compliance
- Oversee and support the implementation of vendor CAPAs
- Communicates with vendors regularly as part of the communication plan to drive a desired state of collaboration.
SR. Pharmacovigilance (PV) Operations Associate
Genentech
09.2022 - 08.2023
- Developed job aid for Late Case Investigation Support (LCIS) team on QAQC metrics reporting to the leadership process
- Recommended and implemented improvements on ICSR compliance presentation updates to leadership, highlighting potential risks and trends
- Created audit and inspection readiness playbook for LCIS team
- Lead the IQVIA document system updates, training, business instructions updates, and implementation discussion for PV Operations to a successful launch
- Reviewed and revised source data quality check tracker to implement a new version to target error rate calculations of missed AEs aligning with MAP SOP updates
- Researched and reviewed operational issue log metrics reports on a routine basis, identified required follow-up training, and work with the appropriate PV Operations member to ensure appropriate feedback is provided
- Participated in a successful audit of OST literature as the Pharmacovigilance subject matter expert
- Act as Pharmacovigilance subject matter expert for LCIS, SDQC, and other processes with US PS in the event of audits or regulatory inspections.
Pharmacovigilance (PV) Operations Associate
Genentech
06.2020 - 09.2022
- Established a training curriculum for Source Data quality check onboarding of new trainees
- Implemented source data quality check consolidation pilot project to meet MAP SOP review turnaround time
- Calculated MAP SDQC data review timelines to ensure end to end review process was completed timely by vendors and the internal review team
- Improved LCIS task processes and implemented LCIS guidance document and business process
- Collaborated with global colleagues to investigate license partner late cases, and late cases to health authorities
- Reviewed late case to determine reasoning and RCA/CAPA action needed
- Established OST Literature submission quality check guidance document
- Prioritized audit and inspection readiness activities to meet department objectives of increasing audit preparedness
- Created MAP CTV training curriculum, Reconciliation quality check, and SME transition process
- Provided operational support and collaborates with the Clinical and Vendor Oversight teams to meet operational metrics.
Case Manager/Sr. Case Manager Rituxan and Actemra ASO
Genentech
10.2016 - 06.2020
- Promoted to Senior Case Manager in 2018 leading team projects on process improvements
- Provided guidance and oversight to case managers in the Central US region on high-profile accounts
- Led and prepared the team for the successful ActPen auto-injection product launch
- Partnered with quality and compliance team to pull through adverse event training for new case managers
- Completed monthly call quality and case review calibrations with the vendor, CenterFirst
- COVID-19 Core Team representative providing updates on tracking patient/customer calls volumes
- Developed and Implemented COVID-19 Business Continuity plan for Rheumatology Access team
- Created task schedule for territory coverage support to manage team's daily inventory
- Enhanced benefits verification process to maximize time spent on reviews which resulted in time savings
- Home Base Trainer lead established training curriculum on new system updates, created training roadmap for case managers, and trained over 60+ new hire
- Reviewed process for assigned projects, updating SOPs, and filing deviations as needed
- Collaborated with copay vendor lead and Patients Customer operations to implement copay card enrollment portal
- Compliance lead providing feedback on case and call audit/quality reviews
- Documented patient progress to maintain a record of case activity and generate statistical reports.
Interim Supervisor - Access Solutions Rheumatology
Genentech
10.2018 - 03.2019
- Prepared contracting team for Blizzard 2019 ensuring project objectives were on target and leading to a successful implementation
- Prepared reports and led leadership huddle providing stats, using Qlik, on throughput, utilization, attendance, uptime and production rate
- Provided updates on upcoming projects, strategies and process changes at operations meetings
- Handled escalated calls for customer questions, feedback, and complaints
- Set performance goals for staff members and helped teams meet important deadlines
- Delegated tasks to team members according to individual strengths
- Conducted employee evaluations and documented overall progress
- Assisted managers with employee recruitment and interviews
- Coordinated manpower requirements by increasing or decreasing personnel and overtime to meet changing conditions
- Organized workflow tasks to prevent downtime and production gaps.
- Oversaw daily operations of the department, ensuring smooth workflow and timely completion of tasks.
Education
MBA - IT Management
Western Governors University
05.2001 - 05.2024
Bachelor of Science - Health Care Administration
California State University - Sacramento
Sacramento, CA 05.2001 - 05.2012
Skills
Risk Management
Project Management
Training and Development
Vendor Management
Process Improvement
Quality Assurance and Compliance
Audit and Inspection Readiness
Data Analysis and Reporting
Leadership and Supervision
Issue Resolution
Effective Communication
Organizational Skills
Timeline
SR. Pharmacovigilance (PV) Operations Associate
Genentech
09.2022 - 08.2023
Pharmacovigilance (PV) Operations Associate
Genentech
06.2020 - 09.2022
Interim Supervisor - Access Solutions Rheumatology
Genentech
10.2018 - 03.2019
Case Manager/Sr. Case Manager Rituxan and Actemra ASO
Genentech
10.2016 - 06.2020
MBA - IT Management
Western Governors University
05.2001 - 05.2024
Bachelor of Science - Health Care Administration
California State University - Sacramento
05.2001 - 05.2012
Vendor Strategy Lead
Genentech
9 2023 - Current
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