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.

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.
• 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.
• 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.
• 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.
• 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.

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.
• 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.

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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

Ph. D., Pharmacy Administration

Bs, Pharmacy