Dolores Radiceska

Responsible for collaborating with the Head of Medical Safety

Project manager

Informal leadership of undergraduate intern

Analyzed over 15,000 medical device complaints and adverse events

Identified severity of harm of adverse events and severe adverse events

Identification and literature research of drug interferences

Medical risk assessments

Support adoption of new International Medical Device Regulators Forum (IMDRF) Code Regulation

Perform MedDRA and WHODrug coding for all Roche Diabetes Care clinical studies

Knowledge in regulatory affairs and work in cooperation with authorities such as FDA, EMEA, and ISO

Support strategic publication planning by identifying gaps in Medical Device Safety.

Return on investment analysis for Medical Device Safety

MedCIN Content Manager

Maintained databases and identified trends focused on potentially reportable incidents

Departmental documentation audit

Key Initiative: Represented Roche by attending the American Diabetes Association Conference in San Francisco within a month of hire date

Literature Review on Post-Market Safety Signal Detection for Medical Devices

Create Post-Market Surveillance Reporting Process

Create standard operating procedure for Post-Market Safety Signal Detection Reporting

Key Project/Initiative: Created standard operating procedure and reporting process for Roche Diabetes Care to establish how safety signal detection is monitored

Utilization of Salesforce software and databases

Analyze and develop comprehensive reports to support post-market safety surveillance

Key Project/Initiative: Responsible for reviewing reportable events based on the level of patient harm while identifying any trends or patterns within the data

Responsible for maintaining large datasets related to Health Professional Shortage Area Designations (HPSAs).

Project Management

Led efforts in gathering, managing and synthesizing survey data for the team to conduct and finalize analyses

Supporting Program Coordinator with administrative/clerical duties

Key Project/Initiative: Assisted with preparation for Governors Workforce Council Meeting. Efficiently typed meeting minutes.

Followed protocol in gathering provider data for primary care physicians, specialists, and psychiatrists in the state of Indiana

Managed survey data and reported any discrepancies

Completed over 15,000 verifications in an efficient manner

Key Project/Initiative: Responsible for identifying risks in provider data used in Health Professional Shortage Area Designations (HPSAs.) Provided recommendations and rationale for preparing for the next round of verifications.