Diana Rinner Email & Phone Number

Fullerton, Ca, Us

Durham County, North Carolina, United States

Provide oversite of PV System database and associated technical systems and platforms, including management of associated vendors and safety system users.• Serves as subject matter expert on Argus processes and internal system related SOPs.• Oversees and manages safety database configuration, data migration initiatives, dashboard configuration and gateway implementation.• Provides technical expertise about data entry conventions and database infrastructure setup during client onboarding and start-up.• Responsible for establishing and overseeing workflow and reporting rules within safety systems in accordance with contractual obligations as well as FDA/International regulations and applicable ICH/GCP guidelines.• Oversees all regulatory reporting for assigned projects, ensuring the safety systems support reporting and are performed in full compliance with FDA/International regulations and applicable ICH/GCP guidelines.• Manages communications between appropriate team members and safety system users, associated vendors, Quality, Regulatory, Clients, and Sponsors when safety issues are identified.• Conducts training sessions and workshops, including presenting reports from any conferences attended, as agreed.• Oversees monitoring of compliance metrics to ensure regulations and timelines are being met for expedited, periodic reporting, and SDEAs.

Irvine

• PV System Support and Administration Activities• Develops Argus and Business Objects reports to support PV Operations and other GPSE functions• Develop advanced query conditions for data retrieval.• Provides ad-hoc data query support• Facilitates and manages the review and maintenance of GPPC reporting rules• Facilitates and manages the review and maintenance of the configuration of GPPC listed events per product• Facilitates and manages the review and maintenance of GPPC business codelists• Facilitates and manages the setup required for new business partners• Provides business support for the establishment of E2B report exchange activities• Provides business support for the migration of safety information

Foster City

• Report Writer to support Drug Safety operationso Checking Datamart for failed reports and creating/amending report schedules as appropriate o Authoring/Validating/QC of Datamart report requests o QC of Systems requests as appropriate o Update the issues log as appropriate• Creating and generating PSUR/Periodics/PBER reports within Argus Safety to support Drug Safety Department• Responsible for Drug Safety systems projects• Support PV Department with Business Practices, includes test and refine application configuration to align with business needs.

Morristown, New Jersey

• Managing service and client relationship including escalation and oversight of client projects and implementations, execution of account activities and building relationships with client contacts resulting in strong client loyalty• Make recommendation to Clients with Argus Safety Database configuration• Assist with helpdesk ticket that relate to Argus Safety Database/ESM/Reporting• Assist with custom reports using Crystal Reports• Assist with any training within Argus Safety 7.0

• Development of SOPs, guidelines, and conventions for data management processes• Database Administrator for Argus Safety Database• Performs queries and retrieves data from the Drug Safety database for routine and adhoc reports and interacts with Regulatory Affairs on issues pertaining to submission of appropriate reports to Global country authorities• Global trainer for Argus Safety, PSUR Reporting., Cognos and Empirica Signal database• Mentoring/training of local staff on SOPs and system configuration• Implementation of electronic E2B submissions to Regulatory Authorities World Wide• Generate reports for Signal Detection using Empirica Signal database and Argus Database• Generate Summary Tabulations and PSUR Reporting using Argus Safety Database.

• Develop or modify Crystal Reports and PL/SQL procedures• Reverse engineer Design Specifications and Functionality specifications for several different applications• Apply system hot fixes, patches and upgrades• Develop and plan for new system installations and migrations.• Support Project manager and team with testing and documentation for IT Project• Installed and configured Cyclone server(s) (Axway) for testing /production environment to exchange data with FDA (AS2 format), EMA and other partners Recognition for being one of the first companies to succeed in submitting electronic test cases to FDA

• Reviews, analyses and modifies programming systems including coding, testing and debugging to support our workers compensation organization’s application systems (Lytec)• Creates adhoc reporting to support management, accounting departments• Consults with users to identify current operating procedures and to clarify program objectives• Configured and trained users on how to use scanning software Onbase• Assists in identifying and selecting possible system solutions. Involved in numerous projects (Scanning, new applications, system upgrades).

• Analyze information systems and data input/output• Design integration interfaces• Create adhoc reports• Provided IT help desk technical support; resolve PC and network complex problems on Windows• Provide user training• Revise/create policies and procedures for new systems• Involved with numerous projects (Pay for Performance, HEDIS, System upgrades) within the company.• Monitor electronic eligibility in loads, create all financial reports, reconcile capitation against our Manage Care System (AMISYS).• Monthly capitation variance under 3%. Created a process for comparing capitation payment to providers saving the company approximately 1.2 Million in recovered capitation over payments

• Responsible for handling high volume of provider telephone calls related to contract reimbursement and other claims issues• maintained high production and quality standards while operating within rigid departmental guidelines• managed all audits, producing paid/denied and timeliness reports on a monthly basis

• Supervised four clinics (Multi-specialty, Pediatrics, Behavioral Health) of all billing and reimbursement procedures;• Maintained system files for in-house claims editor• Administrator for Set up and maintained electronic billing, CPTCodes/ICD9 updates• Responsible for closing end of month• Provided reports and queries to clinic administrator, accounting department and board of directors for financial performance of all four clinics

• Processed HCFA and UB claims for re-pricing• Submitted claims to insurance companies• Posting insurance payments• Printed physician reimbursement checks to all participating providers.