- Overall in-charge of day-to-day case processing activities including SLA monitoring and compliance focus on operations.- Maintaining, monitoring and tracking records relating to training, productivity, compliance and quality of Drug Safety teams- Performed SAE reconciliation (Licensee reconciliation) as per client (Licensee partner) requirement including tracking and all adverse event reports received and completed.

Assist the clinical team in monitoring the safety profile of product.Coordinated the activities for collection of CRF and various internal study related activitiesReporting of documented as well as non-documented AE and ADR, SAE event as per the regulatory and sponsors guidelinesEnsuring development of study that specific activity which should comply with ICH-GCP.Assist in review of clinical study protocols/reports/other regulatory documents as needed.Clinical study report and proceeding for various QA-QC activities. Scientific literature survey of different pharmaceutical drugs, chemicals and intermediates products In house activities for already selected sites.Sending regular updates to the sponsor and the EC and informing them about the status of study.Ensuring that the rights, safety and well being of study subjects are the first considerations. Interest of the study subjects will take precedence over interest of science and society.Build procedures in compliance with established guidelines and regulatory requirements for BA/BE studies.Ensuring development of study that specific activity which should comply with ICH-GCP. Work with clinical operations and data management to resolve safety data collection. Ensure accuracy and quality of all adverse event reports from Investigator and evaluate adverse event reports from Investigator in timely manner.Timely escalation of all the issues to the project manager.To be well versed with audit preparation plan.Mentoring Skill: Training / Developing junior staff - By Mentoring, Report review, conduct training for junior staff.