Hal Ward Email and Phone Number

Pharmacovigilance support, including:SOP and Work instruction authoringSignal detection and signal managementIndividual and aggregate report reviewPharmacovigilance writing (DSURs, Investigator Brochures, Reference Safety Information, White Papers)Inspection and compliance support

Responsible for PV Program Management for the following TransCelerate initiatives:Advancing Safety AnalyticsIntelligent Automation Opportunities In Pharmacovigilance Value of Safety Information Data SourcesPharmacovigilance AgreementsInterpretation of Guidances and Regulations- PV

Directs the operation and develops the overall strategy of the Drug Safety Surveillance Department. Coordinates the activities of the safety data processing team in order to ensure prompt, accurate individual case safety reports and aggregate data in compliance with applicable global regulatory requirements. Responsible for the validated state and the overall function of global drug safety systems technology.Leads the signal detection and evaluation process at Kyowa Kirin Pharma. Creates safety signal analyses, reviews scientific literature, assesses safety reports and white papers, and creates individual and aggregate reports.

• Lead and manage pharmacovigilance personnel in the performance of all safety related tasks for clinical trials contracted by Premier Research. This includes (but not limited to): creating safety plans for new projects, implementing the tasks stated in the safety plans (e.g. answering protocol related questions, processing of SAE’s, lab and EKG alerts, entering SAEs in the safety database, collaborate with DM in reconciling SAEs periodically, attend project team teleconferences as needed, etc.). • Review the department processes and workflow periodically to assure that the best practices for all tasks are adopted and reflected in the department’s SOPs.• Provide continuous monitoring of projects under their charge to ensure that all department procedures, SOPs, and safety plans are adhered to. • Monitor the department projects to assure that the teams adherence to the scope of work contracted and the allocated hours by the contract• Training and mentoring the more junior members of the team and new hires to the pharmacovigilance group. • Assuring that the appropriate resources are in place for effective and successful execution of the department’s projects.• Monitor the department financial and non-financial metrics and report periodically to Premier Research senior management.Consulting with client companies in order to improve processes, gain efficiencies, save time, and improve compliance.

• Overall responsibility and management of the Global Drug Safety Group• Responsible for the successful planning and forecasting of global resources for the completion of client projects for the Global Drug Safety Group• Responsible for creating and implementing training and development plans for the Global Drug Safety Group• Responsible for establishing, developing, maintaining and revising of quality performance metrics, to ensure continuous improvement in the areas of productivity and quality. • Global responsibility for meeting and exceeding operational activity through operational efficiency, global standardization and implementation of process improvements and standard operating procedures• Input into the Proposal Development and bidding process. • Direct supervisory responsibility for Regional Directors within Global Drug Safety Group• Support endpoint review committee and DSMBO