Management Medical

DANIEL S. SUM, Ph.D., R.Ph.

** ******** *****

Princeton, NJ 08540

908-***-**** ********@*****.***

HEALTH CARE PROFESSIONAL

Extensive experience specializing in all aspects of Global Pharmacovigilance Operations within the Pharmaceutical Industry. Proven record of success in organizational development and team building with additional experience in leading global teams to develop new, or improve existing processes and systems that increase efficiency and effectiveness. Strong knowledge of global regulatory requirements with specific expertise in handling regulatory inspections.

PROFESSIONAL EXPERIENCE

SANOFI-AVENTIS, Bridgewater NJ 2005 – 2011

Sr. Director, System Support Unit (2005 – 2011)

Provided ongoing system support for pharmacovigilance activities including: E2B implementation, development of new global system, timely generation of validated reports to support routine and ad hoc reporting needs, and ongoing validation needs.

• Led multiple work teams to modify legacy Aventis Clintrace system to support a new post-merger pharmacovigilance paradigm, thereby allowing the organization to integrate operations across two global sites while simultaneously developing a new, integrated global database.

• Identified a strong outside resource to guide internal resources on the development of entry and administrative aspects of a new global AE system. This led to a 30% reduction in the time required to develop functional specifications for these deliverables.

• Managed resources in Bridgewater to ensure proper support for development of the new system while ensuring coverage for ongoing SSU activities without the need for additional resources over the course of the project.

• Implemented a Global Analytics Plan encompassing overall Governance, Standardized Report development and Ad Hoc Report generation following implementation of a new global Adverse Event system. This plan allowed programmers to work around technical challenges resulting from the new system implementation to provide standard and validated ad hoc reports to support pharmacovigilance activities.

• Led teams to implement multiple technical solutions to increase the efficiency and effectiveness of global pharmacovigilance activities.

Created new reports to support regulatory reporting activities of local country affiliates, resulting in a 50% decrease in reporting time required for many countries.

Developed and deployed web based reports to be run by users allowing for a 60% increase in reports generated without an increase in number of programmers.

• Led a team to develop an automated solution for the generation of tables and listings needed to support Periodic Safety Update Reports. Implementation of this tool enables the replacement of contract resources with an immediate savings of $160K annually.

Head, Case Management Processing Unit (2009 – 2010)

In addition to System Support Unit activities described above, responsible for case entry and medical evaluation of individual cases to ensure processing was completed within timelines consistent with regulatory and internal requirements.

• Implemented new processes and procedures to eliminate a 3 month backlog within 6 weeks.

• Led a cross functional team to enhance internal processes for reconciliation of serious adverse events from clinical trials, resulting in a 25% reduction in time required for the GPE activities.

DANIEL S. SUM, Ph.D., R.Ph.

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SANOFI-AVENTIS (continued)

• Developed a business case and metrics to justify the need for additional case management resources during the pre- and post-system implementation phase to deal with an expected loss of productivity associated with the new system. Handled vendor negotiations and instituted a governance model to provide ongoing management of these relationships. This allowed the Case Management group to quickly return to their pre-implementation productivity level with good compliance demonstrated by a favorable audit of these activities during an FDA inspection.

AVENTIS PHARMACEUTICALS 2000 – 2005

Head, Pharmacovigilance Operations

Responsible for pharmacovigilance operations, including individual case management, report generation for routine or ad hoc surveillance requirements, FDA reporting, ongoing system support, new system development, and device reporting and surveillance activities.

• Business leader for the ARGUS system development/implementation activities. Managed vendors, oversaw development of user requirements, determined data output and reporting tools, and procured resources to handle validation activities. The project deliverables were completed on time.

• Partnered with the Global Quality organization to develop a business case for, and implementation of, a Global Medical Device Surveillance Group. Developed processes and procedures for handling, analysis and reporting of device adverse events. This group provided rapid responses to regulatory or technical issues associated with devices, thereby preventing negative regulatory actions.

• Developed and implemented a Clinical Area Support Team, a group of non-MD health professionals dedicated to supporting the medical staff in the generation of regulatory reports, and addressing regulatory issues on company products. This provided a career path for these professionals while also cutting departmental costs by decreasing the number of physicians needed to support the products.

• Directed transition of Case Management Operations activities to Bridgewater as part of the Hoechst-Marion-Roussel/Rhone-Poulenc-Rorer merger. The transition was accomplished with minimal impact on global compliance as demonstrated by a positive FDA inspection in France within six months of the transition.

• Acquired responsibility for US Pharmacovigilance in addition to global responsibilities. Successfully implemented new processes and procedures allowing a staff of 25% fewer associates to handle a steadily increasing volume of adverse event reports. These processes and procedures were successfully reviewed without issue during two FDA inspections.

HOECHST MARION ROUSSEL 1998 – 2000

Head, US Pharmacovigilance

Managed medical and regulatory activities for the US Pharmacovigilance Affiliate.

• Responsible for US Affiliate activities for Hoechst-Marion-Roussel, managing a $2.2M budget and staff of 22, including 2 physicians. Successfully transitioned these functions to Bridgewater, NJ following a decision to close operations in Kansas City.

• Provided medical support for potential safety issues arising from manufacturing issues.

EDUCATION

Ph.D., Pharmacy Administration, University of Missouri, Kansas City, MO

B.S., Pharmacy, University of Missouri-Kansas City, MO

PROFESSIONAL DEVELOPMENT

Multiple Presentations at Drug Information Association Annual Meetings.

Co-chair of Oracle AERS User Group (2 years)

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