Tracey Hall Email and Phone Number

Managed PV and safety monitoring of three anti-infective development programsEstablished company PV processes and SOPs to align with current GPV regulations and guidanceDeveloped and implemented a company safety governance structure through establishment of safety boards and creation of signal detection and management proceduresImplemented a PV compliance system to ensure adherence to internal processes as well as safety reporting timelinesSupported NDA as part of a labeling working team and FDA request response teamCoordinated safety board and executive safety committee discussionsProvided oversight of DSUR development and maintenance of product IB safety sections and Reference Safety Information

Global safety lead for a worldwide marketed oncology productManaged the safety profile of a marketed oncology product through the monitoring of cases received from multiple worldwide markets, as well as from clinical trials, investigator-initiated research, and compassionate use Coordinated with a cross functional project team including regulatory, clinical science, product labeling, and biostatistics in the development of global regulatory submission strategies and regulatory filingsRepresented PV in discussions with FDA and other health authorities regarding regulatory filings and submissionsCollaborated with several global licensing and distribution partners and regional marketing authorization holders in the development of PV agreements, regulatory submission strategy, and management of product safetyManaged responses to health authority safety inquires, providing guidance to team of PV scientists in the evaluation and analysis of dataProvided oversight in the investigation of potential safety issues and advised team of PV scientists on appropriate course of actionPerformed oversight of the authoring and review of PBRERs, DSURs, and other periodic safety reportsRepresented PV team in cross-functional senior leadership meetingsProvided mentoring and oversight to team of PV scientists performing review of aggregate post-marketing and clinical trial data, signal management, development and management of regional risk management plans, and contribution to investigators brochures, study protocols, clinical study reports, and other documents

Performed review of aggregate safety data from oncology clinical trials and review of individual case studies, in collaboration with team physician and clinical researchCoordinated with regulatory team to successfully fulfill several FDA post-marketing commitmentsPerformed a comprehensive evaluation of aggregate safety data from clinical trials and post-marketing exposure, relevant literature, and current medical practices to revise the identified risks in the risk management plan for a global oncology productSummarized serious adverse event cases and prepared slides for presentation to global safety teams, providing recommendations where neededUpdated product Reference Safety Information and safety sections of IBs Authored safety reports including descriptions of aggregate safety data and discussions/conclusions of annual review of clinical trial data for DSURsDocumented all review and oversight of safety information as required per company and health authority regulations

Performed medical review of clinical and safety data from two global clinical trials in diabetic neuropathy Reviewed study data prior to regular clinical team meetings and prepared and presented data summariesCollaborated with study physician to investigate any safety issues and obtained follow up information as necessaryMonitored reports of serious adverse events and ensured that follow up and supplemental information was received as neededCollaborated with the medical and biostatistics teams in the review and analysis of final data and summaries of study resultsManaged the clinical aspects of a global clinical trial in muscular dystrophyReviewed all clinical and safety data and escalated issues to safety physician as necessaryManaged study protocol conduct at investigational sites and assisted site staff with any protocol-related or logistical questionsActed as liaison between site monitors and study coordinators, addressing any site monitoring issues as necessary