Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Thiruvananthapuram

Description

Job description


Supervise and support the work of a team of direct reports who:


o Provide technical support for a range of PV systems in accordance with regulatory requirements and agreed processes;


o Perform activities related to the implementation, maintenance and termination of SDEAs


Ensure timely production of key deliverables by staff, including:


o Communicating with stakeholders to ensure PV system help desk ticket requests are appropriate, complete and approved and resolving tickets within agreed timeframes and to expected quality standards


o PV Reports and Queries


o OASIS database configuration changes


o Configuring safety data and SDEA-related information within the GSK Safety and Pharmacovigilance Agreements (PVA) databases and supporting maintenance of these and other PV systems


o Delivering safety data and PVA reports through analysis of end-user requirements and development, testing and delivery of custom reports (including reports produced for global regulatory inspection and audit purposes)


o Ensuring SDEA compliance through monitoring, reconciliation, quality control and support for oversight


o Delivering training and/or project support as required


Balance resource requirements across the portfolio and promote a pragmatic, flexible, focused approach to workload


Ensure that direct reports have business objectives set, development plans in place and complete all assigned training


Develop and share technical, pharmacovigilance, SDEA and PV systems knowledge and experience with team members


Collect data on time, cost, quality and compliance and ensures team meets targets for all measures including defined Key Performance Indicators (KPIs) and conduct management monitoring of activities carried out by the team


Aid direct reports with decision-making, problem solving and work prioritization; provide review and quality check support as required


Participate in quality or continuous process improvement activities related to area of responsibility or as requested


Maintain appropriate organizational networks


Recognize matters that affect corporate or agency policies and escalate issues with high business impact or risk.


Recruiter: Kavya


Email: kavya.x.hv@gsk.com

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