Lisa Belisle Email and Phone Number

Member of the vendor management team of a major pharmaceutical company that provides oversight to vendors contracted to provide global pharmacovigilance services. Duties include workflow management, issue escalation and resolution, document authoring and review, transition planning, client communications, and IT systems support and oversight.

Manager of a full service global pharmacovigilance team, which provides data and services to meet regulatory requirements around drug safety and support risk management programs for drugs and biologics throughout the product development and commercialization lifecycle. Duties include day-to-day management and mentorship of the pharmacovigilance staff with 12 direct reports in multiple offices, global workflow oversight and management of both US and India case processing teams, regular client interaction regarding project needs, training, quality metrics, global workflow management and regulatory compliance.

Project team member for significant full service pharmacovigilance contract. Duties include internal project quality auditing and regulatory reporting, training coordinator for new hires and current team members, foreign case assessment, and processing and reporting adverse events in an accurate and timely fashion to the FDA and foreign authorities ensuring all regulatory and sponsor requirements are met.

Member of a Laboratory Information Services team which supported patient electronic medical records for over 40 hospitals throughout the United States. Built and maintained laboratory services functionality in Cerner Millennium for Trinity Health facilities. Routinely monitored and resolved system errors and assisted clinicians with medical record access. Functioned in a project lead role for new hospital electronic medical record implementation.

Project team lead for significant full service pharmacovigilance contract. Duties included mentoring team of ten associates, training, client relations, process development and quality improvement. Processed and reported adverse events in an accurate and timely fashion to the FDA and foreign authorities ensuring all regulatory and sponsor requirements were met.

A member of a CAP-accredited and GLP-compliant clinical pathology laboratory responsible for the safety assessment of novel drugs generated at the Ann Arbor facility from the discovery phase through first-in-human testing. Served as a clinical chemistry laboratory lead responsible for management of all daily laboratory activities including operation and troubleshooting of instrumentation, preventative maintenance, calibration, linearity, reagent inventories, and colleague training. Monitored approximately 15 preclinical GLP and Phase I clinical trial studies per year ensuring accuracy and timely turnaround of laboratory data used for submission in FDA reports.

Faculty member of the School of Health Sciences responsible for advising, teaching, and mentoring students in the Medical Laboratory Sciences program.

A member of the technical service department of an FDA- regulated developer, manufacturer, and distributor of clinical chemistry reagents, quality control material, and clinical chemistry instrumentation.

A member of the laboratory staff of an approximately 900 bed, Level I Trauma hospital responsible for performing patient testing in all areas of the clinical pathology laboratory. Performed patient testing in the areas of urgent chemistry, hematology, coagulation, urinalysis and microbiology.