Daniel Sum Email & Phone Number

Abingdon, England, Gb

Cambridge, Massachusetts, Us

Development and maintenance of new PV Operations organization to support Alnylam development compounds

Seoul, Gangnam-Gu, Kr

Responsible for:*Development and maintenance of processes to support receipt, processing and reporting of investigational and marketed products. *Led transformation of PV Ops processes to support globalization efforts*Responsible for Partner and Vendor management

*Managing and monitoring of adverse event processing, handling and reporting.*Development of global pharmacovigilance procedures to support globalization efforts*Regulatory compliance for Pharmacovigilance activities*Management of MI staff to ensure that accurate, unbiased, balanced and timely responses are provided for Medical Inquiries.-Assisted in the development of the PSMF and supporting SOPs to support the EU submission of a New Chemical Entity (NCE)-Modification of AE processes to improve efficiency in anticipation of US launch of NCEProcess and resource changes to address backlog of MI inquiries resulting form the launch of NCE

Paris, France, Fr

Business Lead for ongoing pharmacovigilance system support 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. • 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.

Paris, France, Fr

In addition to the 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.• 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.

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.• 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. 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.

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.

Ph. D., Pharmacy Administration

Bs, Pharmacy