Leading the SQM and focusing on quality system. Working closely with all departments to see the loops in the system and take the initiative of working towards it for maintaining QMS.

Coordinate with internal and external teams including Sponsors for various activities of Projects.Satisfy customer requirements as per Scope of Work and ensures compliance to protocol, applicable regulatory guidelines and SOPs.Prepare, review and update various project related data management documentsTrain study team on Study requirements and ensure optimal resource utilization.Develop Study team members by providing feedback on Study documents and deliverables.Development and Review of SOPs.

• Command over Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook• Proof reading of reports according to pharmacovigilance perspective• Interact with internal or external contacts to resolve issues related to the quality of adverse event reports• Maintain an awareness of global regulatory reporting obligations and organize workload with the team manager to ensure compliance with internal and regulatory timelines• Identify areas of concern within the team and raise the issues with the team manager• Organize the training within the team as per the requirements• Organize the workload with the team manager and coordinate within the team (approximately 40 people) accordingly• Assess the key performance indicator (KPI) for narratives and share the same with the client • Prepare job cards for all the reports and other work done on ERP and send the monthly data for billing • Maintain weekly productivity sheet to keep a track of the workload• Organize weekly peer review sessions for the team to encourage team work• Maintain efficiency of the team on a quarterly basis and compile the data annually in graphs• Communicate important information to the team as and when required• Arrange the relevant documents required during the audit• Maintain a tracker detailing the training conducted individually and the records prepared for all the members of the team• Arrange the training schedule for the new employees• Share the important documents required by the client on shared portal for review

• Microbiological testing of samples• Environmental monitoring programme ( EMP)• Testing of water samples• Streaking and colony count• Disinfectant Validation• Auto pipette Calibration• Balance Calibration