Manager, Medical Information and Safety, office based in Bratislava

PURPOSE

Manage Pharmacovigilance (PhV) staff responsible for adverse event/ICSR/Clinical Endpoint processing and PhV systems to include project resource assignments, staff hiring, personal development and staff terminations. Responsible for facilitating staff training and professional development. Assist in assuring corporate and departmental quality, financial and productivity targets are achieved.


RESPONSIBILITIES

• Manage PhV staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.

• Monitor and motivate staff to achieve and maintain acceptable levels of performance.

• Work closely with other department managers to address problem areas, staffing needs, equipment needs, and department resource planning and work scheduling for current and projected projects to ensure deliverables are met.

• Ensure that staff have been trained on and are following Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Working and Project Instructions.

• Leads and encourage direct reports in continuous improvement of department work processes and infrastructure. Instruct and lead direct reports in efficient management of project budgets.

• Monitor with Program Managers and overall Pharmacovigilance management to ensure that department deliverables meet expected quality, financial and productivity targets. Work with Pharmacovigilance management to ensure department realization and utilization targets are met. Ensure department metrics are collected and meet expected targets.

• Assure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, working instructions and client xpectations.

• Assure that, within the functional group assigned, SOPs and Work Instructions are appropriate and current, and that personnel are trained accordingly.

• Facilitate, develop and implement plans for measuring and improving employee engagement