Assoc Manager, Regulatory reporting (G140)
Buenos Aires, Argentina
hace 6 días

Use your scientific and Pharmacovigilance expertise to join the world’s leading comprehensive pharmaceutical safety services organization on a fast-growing Satefy Ops team.

Apply your expertise, including GVP and / or GCP knowledge, complex decision making and working towards strict deadlines to meet timelines.

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.

Job Overview

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.

Essential Functions

  • 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 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 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.
  • Support or Lead change management initiatives
  • Effectively able to manage People issues
  • Responsible for ensuring 100% compliance towards people practice and processes
  • Qualifications

  • Bachelor's degree in life sciences or related field and up to 6 years of relevant experience, inclusive of up to 4 years of PV experience and up to 2 years of people management experience.
  • Or equivalent combination of education, training and experience)

  • English level : advanced.
  • 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.
  • 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
  • Flexibility to operate in shifts.
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