Job Description
- Implement and support operational decisions as determined and instructed by senior management. May contribute and assist in global initiatives e.g. Change Management; Subject Matter Expert (SME) Committees; SOP Review Committees; Retention, Engagement, training, processes etc.
- Assist in the implementation for measuring and improving employee engagement local and/or global actions. Maintain open and regular communication with direct reports to ensure a supportive working environment.
- Supervise 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 on human resources matters.
- Support the management of project resource assignments staff hiring and staff terminations in collaborations with operations specialist managers. Assists with staff training; professional and career development.
- Work closely with operations managers to address problem areas, work scheduling for current and projected projects, and projected peak workloads. Monitor, assess and report utilization of staff. Identify and implement solutions to address poor utilization.
- 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 Lifecyle 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, 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
Candidate Profile
- Bachelor's degree or educational equivalent in health science or other directly related field and 5 years' clinical research experience in a Contract Research Organization or Pharmaceutical company including at least 3 years of Lifecycle Safety experience(Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management, etc.) or equivalent combination of education, training or experience
- Sound knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills.
- Staff management skills, effective leadership, motivational and influencing skills.
- Ability to work on multiple projects and manage competing priorities.
- Ability to mentor and coach.
- Strong 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.
PHYSICAL REQUIREMENTS
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• Requires occasional travel
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• Requires occasional travel
Additional Information
Experience : 5 years
Qualification : Bachelor's degree
Location : Bangalore
Industry Type : Pharma
Functional Area : Safety Operations
End Date : 10th September, 2018
Experience : 5 years
Qualification : Bachelor's degree
Location : Bangalore
Industry Type : Pharma
Functional Area : Safety Operations
End Date : 10th September, 2018
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