Regulatory Reporting - Manager, Safety Operations Team (Pharmacovigilance) - Remote
- Experience Level
Regulatory Reporting – Manager, Safety Operations Team
Be a part of a global team to help ensure the safety profile of a COVID-19 vaccine with opportunities to improve worldwide public health.
Manage Safety staff responsible for Safety Operations processing in alignment with departmental and corporate standards. Contribute to Global initiatives. Work in close collaboration with SM and other relevant stakeholders supporting the achievement of local and global deliverables and metrics.
Contribute and assist 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 Safety Operations staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work
Performance appraisal and professional development guidance
Addressing employee relations issues
Resolving problems and absence management.
Management of project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. Assists with 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 Safety service offering
Monitor and develop training plans
Identify training and development needs of staff in collaboration with Training team and Safety Management.
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, 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, work 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, Work Instructions and project instructions.
Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.
Perform other duties as assigned
Ability to track and monitor project financials and budget
Ability to independently engage customers on escalation and scope expansion
Responsible for ensuring 100% compliance towards people practice and processes
Qualifications and skills:
5 years + pharmacovigilance experience
Lifecycle or Healthcare degree
1-2 years team management experience
Proven Staff management skills, strong leadership, motivational and influencing skills
Ability to work on multiple projects and manage competing priorities.
Effective mentoring and developed coaching skills.
Excellent presentation, report writing skills and customer focus skills.
Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities.
Sound judgment, decision-making and problem solving skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Understanding on basic Project Finance - Extensive use of keyboard requiring repetitive motion of fingers.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.