Associate manager, Safety Operations (Pharmacovigilance)

Job content

Sub Family Description

Manage Safety staff responsible delivering services in Safety Operations under the guidance of senior management. May contribute to Global initiatives. Work in close collaboration with Senior Management and other relevant stakeholders supporting the achievement of local and global deliverables and metrics.

Job Profile summary

• 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 Safety Operations staff in accordance with organizations 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 on 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 Safety service offering as applicable; 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.

Knowledge

• Sound knowledge of Safety service lines; willingness to increase knowledge across 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.
  • 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.
  • May require occasional travel.
  • Ensure quality of deliverables according to the agreed terms
  • Demonstration of IQVIA core values while doing daily tasks
  • Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations.
  • Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders.

Skills and Abilities

• Extensive use of keyboard requiring repetitive motion of fingers.
  •Exte nsive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.