* 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 NCE * Process and resource changes to address backlog of MI inquiries resulting form the launch of NCE

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. Show less

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.

* 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

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