George Phillips, Pharm.D. Email & Phone Number

Raleigh, North Carolina, United States

Durham, North Carolina, United States

Durham, Nc

Responsible for the establishment and subsequent managerial oversight of the investigational and postmarketing drug safety and pharmacovigilance function, development and execution of the vison and long-term strategy for the department, implementation of a proactive safety surveillance and signal detection/risk minimization program, compliance with all applicable global regulatory requirements, and timely awareness and adaptation of evolving global safety-related regulatory requirements.  1) Develop and maintain SOPs and working practice documents. Key responsibilities: 2) Implementation of a proactive safety surveillance and signal detection evaluation program. 3) Oversight of aggregate safety data reviews and report completion (DSURs, PSURs, PADERs, NDA Annual reports, etc.). 4) Preparation of responses for safety-related questions from regulatory authorities. 5) Present at external meetings with regulatory authorities, partners, investigators. 6) Ensure departmental budgets are in line with corporate requirements. 7) Provide ongoing updates, advice and guidance to senior management on the changing risks-benefit profile of development assets, in-line products, and relevant disease areas and implements appropriate safety updates and risk mitigation plans. 8)Assure appropriate standards are maintained for regulatory inspections. 9) Oversight of CCSI and safety sections of protocols, investigator brochures, product labeling.

Morrisville, Nc

Responsible for overseeing the daily operations and long-term goals of the post-marketing safety team, signal detection team, and centralized literature team. Provide strategic direction, leadership and management across multiple company divisions to help direct the delivery of projects and programs within cost, time and quality requirements. Assist with business development activities, obtain additional contracts, write and review proposals, make presentations to potential clients, and represent the department at key professional meetings and conferences. Explore the feasibility and establish requirements for creating pharmacovigilance consultative services as a company offering. Key responsibilities: 1) Provide direct supervision, support, training, and mentoring of Associate Directors/Directors and other assigned staff. 2) Collaborate with other members of the pharmacovigilance global management team. 3) Propose, direct, initiate, and guide new departmental and corporate initiatives. 4) Development and implement a department wide pharmacovigilance training program utilizing novel training software 5) Identify unusual or significant problems encounters with global safety processes and propose strategies for mitigating and preventing future occurrences. 6) Ensure assigned projects are appropriately resourced, managed and executed. 7) Manage overall budgets for assigned projects 8) Foster client relationships and supervise strategic sell initiatives of the department.

Chapel Hill, Nc

Responsible for driving and executing the strategy for the Safety Software Product Unit, utilizing industry experience and expertise to ensure the organization’s safety strategy aligns with customer priorities and global regulatory requirements. Key responsibilities: 1) Meet with key customers and thought leaders on a frequent basis to ensure product innovation and evolution is in concert with current and emerging safety trends.  2) Chair the company Safety Advisory Board and Industry Standard Platform to ensure the vision of the Safety Software Unit is aligned with customer expectations and regulatory requirements. 3) Provide expert knowledge-based input to sales, marketing, global delivery, and global development in support of the company mission to expand its footprint in the pharmacovigilance space. 4) Serve as the primary liaison with regulatory authorities on behalf of clients, as needed. 5) Identify, evaluate, and help direct the development and implementation of new automated safety solutions that increase client productivity, quality, and compliance.

Raleigh, Nc

Responsible for ensuring all global and affiliate level company-sponsored social-digital programs are designed and operated in compliance with applicable safety regulations; directing the implementation of and continued oversight of a company-wide governance program for Patient Support and Market Research Programs; establishing a global technovigilance program for company marketed and investigational device products; and providing strategic pharmacovigilance advice. ✓ Serve as a core participant in defining and developing the company culture and strategy with regards to the use of digital and social media. Serve as a Member of the company Global Digital Steering Committee. ✓ Accountable for development, oversight, and execution of strategic pharmacovigilance requirements associated with company social media and digital initiatives. ✓ Co-chair the Task Force charged with the implementation of an overall governance program for patient support programs, and ensure compliance of these programs (and market research programs) with applicable safety requirements.✓ Co-chair the company Task Force charged with establishing a framework which enables UCB to conduct efficient and regulatory compliant investigations with medical devices, wearables, and mobile medical apps.✓ Serve as a member of the UCB Raleigh Site Leadership Team.✓ Make recommendations on integrating emerging technologies into the overall safety business strategy.✓ Serve on expert working panels to proactively discuss and shape industry standards and best practices.

Raleigh, Nc

Campaigned for and championed the transition of the safety department leadership from the US to Belgium headquarters. Subsequent responsibilities consisted of providing strategic and tactical pharmacovigilance advice to the department, overseeing the US pharmacovigilance operations on an interim basis, representing the department on safety-related matters pertaining to social-digital initiatives, and serving as the safety-legal department liaison.✓ Successfully ensured a smooth transition of leadership responsibilities to European headquarters.✓ Served as an advisor of safety surveillance processes and safety-related strategies involving regulatory matters. ✓ Assisted with due diligence exercises with third party endeavors. ✓ Represented the department on project teams involved with external vendors and partners. ✓ Temporarily managed the US affiliate safety organization and ensured it operated in a proactive and compliant manner. ✓ Co-chaired the Case Processing Conventions Committee to ensure regulatory compliant and consistent practices were operational.✓ Served as a core member of the UCB and US Steering Committees for Social Media.

Raleigh, Nc

After the acquisition of Schwarz Biosciences by UCB, named Global Head Clinical Safety & Pharmacovigilance. Led UCB’s commitment and efforts to advance its pharmacovigilance capabilities by implementing a departmental structure and processes that enabled more efficient case processing, safety signal evaluation, and risk management oversight for investigational and marketed products. Managed a departmental staff of 120.✓ Spearheaded the successful integration and globalization of vastly different heritage safety organizations and philosophies. ✓ Initiated and directed the implementation of a new safety database to facilitate global regulatory compliance and credibility.✓ Established a dedicated epidemiology and risk management unit to proactively identify and resolve safety signals or observations in a timely manner.✓ Ensured international regulations were followed regarding pharmacovigilance processes and procedures.

Raleigh, Nc

Hired to direct all operational aspects of the safety department and to serve as Deputy Head. Named Department Head in 2007 with the remit to plan, direct, and execute safety programs for the entire product portfolio. Managed a staff of 60.✓ Developed and executed the vision and mission of the global pharmacovigilance department.✓ Revised the remit of the department and implemented lifecycle product safety management.✓ Restructured the department to gain efficiencies and maximize available talent so as to better align and meet international safety regulatory obligations.✓ Formally established the role of EU Qualified Person for Pharmacovigilance.

Hopewell, Nj

Responsible for re-building the safety-related licensing and partnership function within the safety department. Also served as the initial department contact on product liability matters. Managed a staff of three.✓ Promoted and contributed to the practical implementation of the global governance model for licensing agreements.✓ Managed partner relationships and contributed with due diligence activities.✓ Served as the department expert on the interpretation and application of safety reporting regulations.✓ Assisted with product litigation, as required.

Research Triangle Park, Nc

Assumed leadership responsibility for the Quality Management group within the safety department which was accountable for training, licensing, SOPs, compliance, and other related functions. ✓ Contributed to and implemented policy and plans relating to operations aimed at achieving optimal safety processes.✓ Ensured compliance with international safety-related regulations, as well as company policies and procedures.✓ Served as department resource on the interpretation and application of US safety regulations.

Research Triangle Park, Nc

Upon the merger between SmithKline Beecham with GlaxoWellcome, served as a member of the Safety Executive Team devoted to integrating the safety functions of the two heritage safety organizations. Day-to-day responsibilities remained as immediately below.

Research Triangle Park, Nc

After a reorganization of the Safety Department, nominated to assume responsibility for directing all operational components for the North American safety department. Specifically responsible for daily departmental operations including budget, case processing, license activities, training, SOPs, safety database, and compliance with safety regulations. Indirectly managed a staff of 40.✓ Served as the FDA liaison on safety matters and inspections, as well as the departmental interface with Legal. ✓ Coordinated due diligence activities and ensured the coordination of activities with the UK safety office.

Research Triangle Park, Nc

Recruited and re-hired to oversee the anti-emetic therapeutic area in Regulatory Affairs.✓ Assisted in the development of strategic plans for safety differentiation of Glaxo anti-emetic products.✓ Responsible for the progression of a key blockbuster NDA towards regulatory approval.

Research Triangle Park, Nc

Directed the overall safety function within the organization, with an emphasis on integrating, expanding, and globalizing the safety activities.. Managed a staff of 30. ✓ Enhanced the clinical trial safety processes and procedures ensuring regulatory compliance on a global level. ✓ Advanced the implementation a globalized safety database where none previously existed.✓ Oversaw the development of a postmarketing safety capability.✓ Worked closely with business development; serving as a subject matter expert for potential clients.

Ann Arbor, Mi

Hired to direct and build the global safety organization after the headquarter offices were moved from NJ to MI. Managed a staff of six.✓ Established the strategy and direction for the global safety function.✓ Ensured accuracy of the safety profiles for all company marketed and investigational products.✓ Ensured globalized regulatory compliant processes were implemented and operational. ✓ Furthered the implementation of the safety database system.✓ Trained an entirely new staff.

Doctor Of Pharmacy (Pharm.D.), Pharmacy

🎓 Completed a teaching assistantship while attending graduate school.

Bachelor Of Science Degree In Pharmacy (B.S.)