Samantha Connor Email and Phone Number

• Serve as interdepartmental subject matter expert (SME) on aggregate reports (including but not limited to: PA(D)ER, PBRER, DSUR, SUSAR Line Listings), including in the areas of business database application and regulatory compliance. • Develop regulatory and custom reports for PrimeVigilance and external customers by relaying regulatory/PV knowledge to Oracle Analytics programming team.• Mentor and train internal end-users on Argus reports and report functionality. Identify gaps in… Show more • Serve as interdepartmental subject matter expert (SME) on aggregate reports (including but not limited to: PA(D)ER, PBRER, DSUR, SUSAR Line Listings), including in the areas of business database application and regulatory compliance. • Develop regulatory and custom reports for PrimeVigilance and external customers by relaying regulatory/PV knowledge to Oracle Analytics programming team.• Mentor and train internal end-users on Argus reports and report functionality. Identify gaps in department knowledgebase of Argus reports and work with Director of Strategy to develop a plan for training implementation. Trained and implemented a specialized aggregate reports group within the ICSR management team.• Assist in the testing/validation of Argus Analytics/Business Intelligence reports.• Support in generation of Outputs and Reports (including custom reports).• Support for data migration activities between databases.• Support the Business/Commercial team in PV aspects of the development of contracts and proposals.• Support quality and efficiency strategies within the organization by both identifying gaps in transitional processes and creating new processes. • Support in audits and inspections, both by providing data recommendations/validation and speaking to auditors about internal processes for aggregate reports Show less

Performing activities in the scope of Safety Information Systems Unit within agreed extent and timeframe (including, but not limited to): Cumulative Data Quality Review (development of reports to review the data, ensure consistency across databases), Support in generation of Outputs and Reports (including custom reports), Database set-up support (support to IT), Training on database related processes to ensure quick onboarding, Support for validation of computerized systems (support to IT), and… Show more Performing activities in the scope of Safety Information Systems Unit within agreed extent and timeframe (including, but not limited to): Cumulative Data Quality Review (development of reports to review the data, ensure consistency across databases), Support in generation of Outputs and Reports (including custom reports), Database set-up support (support to IT), Training on database related processes to ensure quick onboarding, Support for validation of computerized systems (support to IT), and Support for data migration activities between databases. Mentoring and training of new and more junior employees within the unit. Support of PV processes related to the database management within PrimeVigilance and also to clients. Writing of PV Operational Guidelines and SOPs in the field of Aggregate Reports. Developing PV training presentations and delivering PV training as required. Support the Business/Commercial team in pharmacovigilance aspects of the development of contracts and proposals. Support quality and efficiency strategies within the organization. Assist in the development of ad hoc reports by collaborating with IT programming team. Show less

Provide pharmacovigilance data analysis and writing expertise as required for preparation of a range of regulatory reports. Responsible for data compilation, validation, evaluation and written conclusions for aggregate safety documents consistent with global regulatory requirements. This includes the scheduling, tracking, preparation and analysis of DSUR, PSUR, PADER, PBRER, trend analysis, and other ad hoc reports requested by clients. Identify and evaluate new safety signals and trends by… Show more Provide pharmacovigilance data analysis and writing expertise as required for preparation of a range of regulatory reports. Responsible for data compilation, validation, evaluation and written conclusions for aggregate safety documents consistent with global regulatory requirements. This includes the scheduling, tracking, preparation and analysis of DSUR, PSUR, PADER, PBRER, trend analysis, and other ad hoc reports requested by clients. Identify and evaluate new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports. Perform signal triage using medical judgment. Perform, as needed, signal validation through analysis and evaluation of safety data, in consultation with the safety surveillance Medical Directors in the group. Show less

Manage Case Processing staff and operational processes for one or more assigned client teams. Ensure team compliance with operating procedures and working practices. Collect and analyze resource utilization data to ensure appropriate numbers of staff and staff assignments. Ensure staff development through appropriate training and regular evaluation and feedback. Analyze operational processes and develop tactics to maximize operational efficiency. This position requires a range of client support… Show more Manage Case Processing staff and operational processes for one or more assigned client teams. Ensure team compliance with operating procedures and working practices. Collect and analyze resource utilization data to ensure appropriate numbers of staff and staff assignments. Ensure staff development through appropriate training and regular evaluation and feedback. Analyze operational processes and develop tactics to maximize operational efficiency. This position requires a range of client support activities including communication, training, and audit preparation Show less

Performed management of case processing quality review function for assigned client teams; including but not limited to: ensuring team compliance to operating procedures (SOPs) and working practices (WPs), reviewing departmental utilization data, providing targeted training and feedback, analyzing quality data, and developing tactics to maximize operational efficiency and client satisfaction.

Served as team lead on large, high-volume client; Reviewed safety reports for both investigative and marketed products; Mentored and trained team members on complex processes; Managed/updated processes through collaboration with client and upper management, including written initial project specific documents (client specific guidelines, data entry guidelines); Gained experience in all aspects of adverse event case processing from clinical and post-marketing sources.

Triaged, evaluated, processed and reviewed safety reports for both investigative and marketed products (including literature reports); Improved client processes by proposing and leading improvement initiatives; Assisted with preparation of regulatory reports.

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