Angela Blount Email & Phone Number

Waltham, Massachusetts, United States

• Compiled client requirements/configurations and developed/executed IQs resulting in over 10 successful on-time implementations/upgrades of the PV Commonwealth Vigilance Workbench (CVW) software in 3 years.
• Facilitated initial User Acceptance Testing (UAT) for the FDA’s FAERS II RxLogix’s PV Signal/PV Reports implementation: tested functionality, tracked issues, coordinated over 20 UAT sessions, and authored 8 scripts.
• Delivered advanced Empirica Signal support to the FDA and other clients: developed custom data mining runs, queries and reports; interpreted results; updated training.

Northbrook, Illinois

• Partnered with the Signal Management Team on FAERS/Vigibase signal detection methodologies, process improvements, and Empirica Signal functionality explorations.
• Developed research reports characterizing the Pharmacoepidemiology of adverse event conditions in general and targeted populations by interpreting literature/data to support risk management plans, signal evaluations.

Bedford, Massachusetts, United States

• Managed technical and business activities associated with FDA multi-center instances (CDER, CBER, CFSAN, and CDRH) of Empirica Signal data mining/signal detection software.
• Generated center-specific Empirica Signal product name standardizations (e.g., drugs, biologics) and supported application maintenance, configurations and upgrades.
• Produced FDA RFP responses; prepared project schedules and status reports; tracked activities and spending to ensure timely and within-budget project completions.
• Developed and delivered FDA center-specific training to Empirica Signal users and provided technical assistance.

Northbrook, Illinois, United States

• Co-led System Application Team in the development and on-time implementation of a safety signal detection and evaluation process.
• Collaborated with software vendor (Oracle) and global colleagues in the development of the functional and design specifications to integrate internal safety data (Argus) and external safety databases (FDA FAERS and WHO.
• Coordinated Empirica Signal drug product, and DME/TME configurations.
• Provided data mining methodology guidance to global safety product teams; assisted in safety signal surveillance, detection and evaluation planning.
• Authored Pharmacoepidemiology sections for mirabegron NDA research reports (Myrbetriq™) and other pre- and post-marketing pharmacovigilance deliverables.

Master Of Public Health - Mph, Epidemiology

Bachelor Of Arts - Ba, Anthropology