Mars Hill University

Associate Director, Global Head of Case Management & Standards at United Therapeutics Corporation

Co-Adjunct professor teaching the Regulatory and Legal Basis of Pharmacovigilance for the Regulatory Affairs and Quality Assurance Graduate Program.

Temple University

Adjunct Professor

United Therapeutics Corporation

Director, Global Head of Case Management & Standards

Strategic PV operations partner for UT Global Product Safety and Pharmacovigilance; Primarily accountable for Global PV Case Management activities, and ensuring compliance standards at 99% and above are met; Accountable for product complaint triage operations, PV related audits and inspections, and overall compliance and quality standards; Participated in multiple strategic initiatives to develop efficiencies in process and compliance

Associate Director, Global Head of Global PV Case Management & Standards

Primary responsibility for oversight of end to end global case processing; Maintained strong knowledge of global safety regulations to ensure all processes and agreements properly account for all global regulations; Develop team strategy for more efficient team structure and design for Case Processing Vendor(s) and Consultant(s); Provide oversight in Quality Assurance of ICSRs, collection of metrics and trending information; Participate and strategize on continuous process improvement efforts in developing, implementing, and documenting all PV training and conventions; Provide oversight and review of all configurations and configuration updates within the safety database; Participate in inspections/audits as a SME for end to end case management; Responsible for all case processing deviation management and root cause analysis (RCA) originating from partners, internal UT GDS staff members, and vendors; Responsible for oversight and adherence to the budgets

Manager, Global PVG Operations

Strategic reorganization of the matrix team; Review processes for gaps and/or potential improvements; Built career ladder within the client services team; Initiated, coordinated and managed completion of many business initiatives (i.e. completing a standard template for costs, proposals, and Task Orders; creation of a standard suite of SOPs and WPs for the Program Director position; organization of Lunch and Learns at the Company; assisted in the implementation and creation of a standard suite of reports within Argus; creation of standard SAE forms for clinical trials; creation of a standard medical review form in compliance with current regulatory needs; creation and implementation of a standard capabilities presentation; creation of role structures within Client Services; etc.); Participated in bid defenses and proposal/RFI responses and presentations; as a Director of Client Services, I also still retained clients, and acted as a Program Director with tasks mentioned below for 10+ clients

Ashfield, part of UDG Healthcare plc

Director of Client Services

Responsible as the Matrix team leader for 15+ clients; Assisted in developing, reviewing, and ensuring adherence to PVAs; Responsible for creation of individualized communication plans for clients and/or projects; Maintained strong knowledge of global safety regulations to ensure all processes and agreements properly account for all global and local regulations; Utilized proven data from clients to liaise with department managers to ensure proper resourcing for all project needs across all functional areas; Proactively sought information about my clients, client competitors, and any relevant information about client products to be able to anticipate threats and opportunities for the client and for Ashfield; Held monthly matrix meetings with all functional areas in the company to communicate client needs, areas of weakness or improvement, areas of strength; utilized RACI charts within this meeting to clearly define timelines and responsible parties; Responsible for building new task orders for clients and managing change orders for clients; responsible for having a well-rounded knowledge of all Ashfield services to effectively implement new and changed task orders; Responsible for any onboarding and/or off-boarding of any client’s or new or amended products; Responsible for completing a monthly project review with all program directors, finance and senior management to present profit, profit margins, and a deep analysis of functional areas; Responsible for providing on time invoicing, timesheet review, and reforecasting; Participated in successful FDA inspection, as well as multiple successful client audits and pre-qualification audits

Program Director

Responsible for overall oversight of PV operations for 10+ clients; Assisted in developing, reviewing, and ensuring adherence to PVAs; Maintained strong knowledge of global safety regulations to ensure all processes and agreements properly account for all global and local regulations; QC'd cases done by other case managers; Responsible for global submissions; Provided directives to case managers on prioritization strategies; Provided measurable, obtainable goals for direct reports; Coordinated reports and deliverables between departments; reviewed billing reports; Mentored and trained case managers and other OMs; Promoted growth within my employees, and constantly looked for growth opportunities with clients; Completed reconciliation for post-marketing and clinical trial reports; Organized and gathered monthly and weekly metric reports for clients and case managers performance; Participated in a successful FDA inspection, and multiple successfully client audits with great overall outcomes; Created AE/SAE forms, Clinical Safety Management Plans, Data Entry Guidelines, Client Specific Guidelines, Communication plans, etc.; participated in SOP development

Operations manager

Responsible for random quality assurance of 20% of all cases within Ashfield PV as a whole; Reviewed percent fail rates across teams for accurate trending across the company to ensure compliance as well as identify any training or process gaps

Manager of Quality Review

Provided directives to other case managers on prioritization strategy; reviewed and provided input to billing reports; Quality controlled cases done by other case managers; case processing of non-serious and serious cases, originating from the post-marketing setting (spontaneous and solicited), clinical trial setting, and cases arising from scientific literature; Completed Secondary QC of cases done by other case managers; responsible for global submissions; Mentored and trained other case managers; conflict resolution between peers; Ran monthly reports for clients; Completed reconciliation for post-marketing case reports and clinical trial reports

Senior Case Manager

Provided directives to other case managers on prioritization strategy; reviewed and provided input to billing reports; case processing of non-serious and serious cases, originating from the post-marketing setting (spontaneous and solicited), clinical trial setting, and cases arising from scientific literature; Completed Secondary QC of cases done by other case managers; responsible for global submissions; Mentored and trained other case managers

Case manager II

Primarily responsible for case processing of non-serious and serious cases, originating from the post-marketing setting (spontaneous and solicited), clinical trial setting, and cases arising from scientific literature; Completed Secondary QC of cases done by other case managers; responsible for global submissions; Mentored and trained other case managers

Case manager I

Primarily responsible for triaging patients; Assisted with many in-house procedures, such as minor surgeries and exams; Performed in-house labs and procedures, such as blood work needing to be centrifuged, urine analysis, strep and mono tests, blood glucose tests, A1C blood tests, EKG’s, and pregnancy tests; Packaged medications for patients to pick up; Led and trained other volunteers.

Three Streams Family Healthcare

Intern/Nursing Assistant

Coordinated the back-to-school book bag drive for abused, neglected and underprivileged children; Organized two of their major fund-raising events - Krop for Kids and Vine to Wine - with the proceeds benefiting the local children’s homes; Communicated with sponsors and donors; filed for non-profit exemptions; utilized Gift Works and Quick Books to maintain donor information.

Friends of Joshua House/Kids Charity of Tampa Bay

Intern

Organized and planned functional events, such as Circus Day, and Open House; Assisted in coordinating activities during the week such as homework sessions, and organized sports.

Beaverdam YMCA

Volunteer

Cared for and maintained horses, including feeding, cleaning the barn and pastures, fixing fences and painting; Assisted with and ensured the safety of handicapped riders; Assisted in the physical therapy of some of the horses, by massage, stretching, and exercise.

Caitlin Keel, PMP