PROFESSIONAL EXPERIENCE

May **** – March **** : Manager, Patient Safety, Solicited Programs Team, Gilead Sciences, Inc., Foster City, CA

●Perform reconciliation with Vendors commissioned for Gilead global sponsored programs (Market Research, Digital Media, Patient Assistance/Patient Support, Specialty Pharmacy)

●Maintain Gilead Global Sponsored Programs (CMAP) Tracker with Gilead Commissioners

●Provide CMAP Tracker for inclusion in the Pharmacovigilance System Master File (PSMF)

●Coordinate Market Research Vendor training via G-Partners

●Provide back up Solicited Program Vendor Zoom training

●Chair weekly Team Meeting

January 2009 – May 2017: Associate Manager, Drug Safety and Public Health, Standards and Collaborations, Performance Metrics Team, Gilead Sciences, Inc., Foster City, CA

●Prepared monthly incoming Licensing Partner compliance reports, requesting corrective and preventative actions (CAPAs) for ICSRs forwarded outside of PVA timelines

●Prepared monthly ICSR and Aggregate Regulatory Compliance reports, identifying sources of late submissions and requesting CAPAs from responsible individuals

●Prepared monthly outgoing Licensing Partner and Distributor compliance reports, identifying sources of late exchange and requesting CAPAs from responsible individuals

●Prepared CAPAs requested by Licensing Partners for ICSRs exchanged outside of PVA timelines

●Prepared monthly internal productivity reports

●Performed monthly quality control data checks of E2B data fields for randomly selected ICSRs

●Performed labeling assessment QC checks per PSUR schedules

●Safety Database expertise with ARISg and Argus

November 2007 – January 2009: Associate Manager, Drug Safety and Public Health, Operations, Gilead Sciences, Inc., Foster City, CA

●ICSR triage/processing/MedDRA coding/narrative writing (ARISg)

●Prepared Investigator Letters/Analysis of Similar Events

●Performed reconciliation between Clinical and Safety Databases

2006 - 2007 Senior Safety Associate, Scios, a Johnson & Johnson, Inc. Company, Mountain View, CA

●Coordinated safety data exchange with Partners/CROs/AROs

●Triaged, tracked, and processed Serious Adverse Event (SAE) Reports

●Prepared SAE information for study adjudication and safety committees

●Prepared information required for submission of IND Safety Reports

●Performed safety review of clinical data

●Performed reconciliation of clinical and safety databases

●Developed study specific SAE process flow guidelines and instructions

2002 - 2006 Senior Safety Associate, Johnson & Johnson, Inc., Mountain View, CA

● Processed Adverse Event Reports

● Performed MedDRA Coding

● Wrote narrative summaries for clinical and spontaneous reports

● Evaluated/classified reports for reporting to regulatory agencies

● Performed reconciliation between the Safety and Clinical Databases

2001 - 2002 Medical Safety Associate, Clinimetrics Research, Inc., San Jose, CA

● Processed and tracked Serious Adverse Event (SAE) Reports for multiple

Pharmaceutical companies

● Wrote patient narratives for final study reports

● Performed safety review of clinical data to identify safety signals

● Performed reconciliation of clinical and safety databases

2001 - 2001 Clinical Science Specialist, Roche Pharmaceuticals, Inc., Palo Alto, CA

● Developed project protocols and case report forms

● Reviewed study metrics and patient status summaries for data inconsistencies

● Wrote patient narratives for final study reports

● Reviewed data listings for safety signals

1994 - 2001 Safety Operations Associate, Roche Pharmaceuticals, Inc. (formerly Syntex), Palo Alto, CA

● Evaluated, processed, and followed-up SAE reports with investigation study sites

● Performed reconciliation of clinical and safety databases

● Wrote patient narratives for final study reports

1989 - 1994 Clinical Study Coordinator, Syntex Inc., Palo Alto, CA

● Coordinated, managed, and implemented Phase I clinical trials

● Recruited subjects

1988 - 1989 Study Coordinator, Pacific Clinical Coordinators, Redwood City, CA

● Coordinated, managed, and implemented Phase I through IV studies

● Recruited subjects

1988 - 1989 Research Manager, Stanford Arthritis Center, Palo Alto, CA

● Coordinated and implemented post-marketing surveillance research studies

● Managed workload and quality of data entry for five employees

1984 - 1988 Clinical Research Associate, Syntex Research, Palo Alto, CA

● Developed protocols and case report forms for Phase III - IV clinical trials

● Performed with investigator selection/site evaluation

● Initiated/monitored/closed out investigational sites

1981 - 1984 Clinical Study Coordinator, Syntex Research, Palo Alto, CA

● Coordinated, managed, and implemented Phase I studies

● Recruited subjects

EDUCATION

● Bachelor of Arts in Psychology, University of California, Berkeley, CA

● Teacher Education, California State University, Hayward, CA

● Medical Assistant Certification, Bay City College, Oakland, CA

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