Safety Operations Manager
Manage Lifecycle Safety staff responsible for SO processing in alignment with departmental and corporate standards. Contribute to Global initiatives. Work in close collaboration with LSM and Lifecycle Safety Infrastructure supporting the achievement of local and global deliverables and metrics.
Contribute, drive and participate in global initiatives e.g. Change management; Subject Matter Expert (SME) Committees; SOP Review Committees ; Retention, Engagement, training, processes etc.
Develop and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment.
Contribute to, implement and support operational decisions as determined and instructed by senior management.
Manage SO staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisal and professional development guidance; rewarding and disciplining employees; addressing employee relations issues; resolving problems and absence management. Approve actions and ensure global consistency as applicable on human resources matters.
Manage project resource assignments staff hiring and staff terminations in collaborations with operations specialist managers. Facilitate staff training; professional and career development.
Collaborate with other operations specialist’s managers to address problem areas, work scheduling for current and projected projects, staffing needs, equipment needs, and projected peak workloads, ensuring global consistency. Monitor, assess and report utilization of staff. Identify and implement solutions for poor utilization of staff, ensuring global consistency.
Ensure direct reports are cross trained on Lifecycle Safety service offering; monitor and develop training plans; identify training and development needs of staff in collaboration with Lifecycle Safety Infrastructure group and Lifecycle Safety Management (LSM).
Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.
Monitor and ensure that project processes and department deliverables meet expected quality i.e. co-ordination of QC, financial and productivity targets. Assist with meeting department utilization and realization targets.
Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, working instructions and client expectations.
Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Working Instructions and project instructions.
Work with LSM constructively in a matrix framework to achieve project and customer deliverables.
Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In-depth knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
Proven staff management skills.
Excellent project management and communication skills.
Strong leadership, motivational and influencing skills.
Ability to work on multiple projects and manage competing priorities effectively.
Effective mentoring and developed coaching skills.
Excellent presentation, report writing skills and customer focus skills.
Ability to achieve results through communication, facilitation in a matrix service delivery environment with shared accountabilities.
Strong judgment, independent thinking, decision-making and problem solving skills.
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree or educational equivalent in health science or other directly related field and 6 years' clinical research experience in a Contract Research Organization or Pharmaceutical company combining 4 years of Lifecycle Safety experience(Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc) and line management experience or equivalent combination of education, training or experience.