Associate Manager, Pharma Covigilance

by Quintiles in Bengaluru/Bangalore
Experience: 4 to 8 yrs.

Job Description

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

RESPONSIBILITIES
Supervise PhV 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 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 managers to address problem areas, staffing needs, equipment needs, and projected peak
workloads. Identify training and development needs of staff.
Lead and encourage direct reports in continuous improvement of department work processes, procedures and
infrastructure.
Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity
targets. Assist with meeting department realization targets

Assist and co-ordinate across other teams in Global PhV with specific project processes requests.
Monitor, assess and report utilization of staff. Identify and implement solutions for poor utilization of staff.
Ensure department metrics are collected and meet expected tar gets.
Assure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA
regulations and guidelines, working instructions and client expectations.
Implement and support operational decisions as determined and instructed by senior management.
Assist management with departmental resource planning and work scheduling for current and projected projects to
ensure deliverables are met.
Remain current with new software/hardware product releases in an effort to streamline and compliment existing
processes through use of software/hardware.
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.
Develop and implement plans for measuring and improving employee engagement.


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