Associate Director PSS

Job Overview:

Responsible for managing the Patient Safety Solutions (PSS) regional operations group (Europe, Asia-Pacific or The Americas). Responsible for ensuring all domestic projects are allocated and set up in accordance with capabilities and current/expected workload, that assigned staff are adequately trained and developed, and that all projects remain on time and within budget. Responsible for ensuring the processing of expeditable adverse events meets the required standard; and submitting these events to the clients and regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for overseeing the provision of this service to clients either as a support function to the client project groups, or as a stand-alone business. It is the responsibility of the post holder to ensure that staff in own downline provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. They will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.

Summary of Responsibilities:

• May manage from 1-5 direct reports and up to 50 indirect subordinates.
• Managerial and Leadership duties and responsibilities:
• Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
• May manage individuals across multiple teams Participate in Fortrea project teams and provide training about adverse event reporting to non-safety personnel.
• Train new employees overall in pharmacovigilance and regulatory reporting.
• Assist with the recruitment of new staff to Patient Safety Solutions.
• Ensure the set up and maintenance of project files and core process files.
• Contribute to the generation and review of Time and Cost Estimates for PSS business.
• Review safety costs for allocated projects, identify out-of-scope/unauthorized activities and work with the appropriate business units to process change orders, expeditiously.
• Review billed time to allocated projects for direct reports.
• Engage in skill assessment and active skill development of direct reports – implementing development plans to ensure talent development.
• Provide appropriate and relevant PSS input into project management, including risk analysis, control metrics and contingency planning.
• Liaise with medical, clinical, data management, regulatory and QA personnel regarding safety issues, as appropriate.
• Support Business Development (BD) activities including client presentations and accurate input for costings and proposals.
• Work with BD Costings and Proposals to provide time and cost estimates for new upcoming projects and staffing needs.
• Provide safety representation on project proposal teams and participate in business development meetings with potential new clients to ascertain their overall safety capabilities and needs.
• Provide input on all safety-related presentations for global use.
• Provide and discuss operational metrics on an ongoing basis to assist with continuous validation of the drug safety costing algorithms.
• Ensure efficient, effective, and economic operation of PSS including management of quality, regulatory compliance, and adherence to project budgets.
• Participate in discussions of planning and review of global/local practices.
• Provide safety data to support regulatory submission personnel for annual reports.
• Review and provide input on global Standard Operating Procedures (SOPs) and Work Instructions (WIs) involving safety, plans and documentation to ensure all PV and DSS units are aware of and work in accordance with ICH, FDA, and Asia-Pacific regulatory requirements.
• Provide review/assessment of requests for project-specific processes and SOP/WI deviations and seek senior management approval, prior to implementation by team.
• Interface with Information Technology (IT) regarding validation and utilization of safety databases.
• Ensure timely and appropriate reporting of expeditable adverse events to clients, regulatory authorities, ethics committees and investigators, as required.
• At times, execute routine quality review of AE reports and aggregate reports for other members of PSS ensuring that case processing and data quality meet global regulatory compliance needs, including audit support.
• Discuss project status at regular meetings with operations staff and ensure tracking sheets are updated appropriately.
• Ensure the effective collection of departmental metrics.
• Analyze metrics results and take necessary actions to en