Amy Mitchell Email & Phone Number

Charlottesville, Va, Us

Charlottesville, Virginia Area

- Serves as representative from SRM for projects; meets all timelines including coding, AE processing, AE/expedited AE reporting, SMMP to client, SAE reconciliation; AE timelines are measured as part of monthly metrics; coding and reconciliation measured with database lock on time. Maintain high level of client satisfaction for all clients; to be measured by feedback received by Manager from internal and external clients.- Participates in Global Regulatory Reporting tasks including: Development of reporting master-list; Communicates understanding of reporting regulations and guidelines; Successful submission to regulatory authorities.- Participates in Safety Reporting tasks including submission of reports to sites and Investigators.- Full case processing and Reporting.- Meets all required timelines with high degree of quality and understanding for: Triage; Assessment; Database Entry (ARGUS); Narrative Generation; Query Management. - Provides full study coverage as back-up Lead Drug Safety Associate on various studies, some of which is long-term coverage.- Lead Drug Safety Associate for phase I and II study- Attends Client Calls and Internal Meetings and provides Safety input when necessary. - Experience reviewing, finalizing Safety Management Plan (SMP).- Modifies and creates SMP appendices.- Review of updated/new SOPs, new training and review of policies by effective date, documenting training/policy/SOP review as appropriate, and communication of completion of training/review and documentation to FM.

Charlottesville, Virginia Area

- Served as administrative support as appropriate for SRM Management and Drug Safety Associates to accurately and efficiently meet all project contractual and regulatory timelines including, but not limited to, Safety Letter distribution, and e-submission of project documents (if applicable).- Served as administrative support as appropriate for SRM Management and Drug Safety Associates in the day to day operational aspects of running the Drug Safety Center.- Reviewed updated/new SOPs, new training and review of policies by effective date, documenting training/policy/SOP review as appropriate, and communication of completion of training/review and documentation to FM- Full comprehension of safety related systems and processes.

Miami/Fort Lauderdale Area

- Established new leads to build clientele, and ultimately exceed monthly sales goals.- Monitored competition by gathering current marketplace information on pricing and products. - Conducted market research to identify potential customer acquisition targets. - Managed customers inventory ensuring continuous fulfillment and customer satisfaction. - Initiated customer relationships and ensured that customers were satisfied with products and services. - Identified optimal product mix to address customer needs and maximize sales. - Developed marketing collateral to support sales process and increase conversion. - Created a company-wide process to streamline drug identification and expedite closing sales. - Awarded two internal promotions within a 2-year period.