Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Reviewing, entering, and tracking SAE data, crafting narratives, and coordinating follow-ups and reporting for assigned projects.Adhering strictly to corporate policies, SOPs/WPDs, and maintaining awareness of ICH GCP guidelines along with relevant global and local regulations.Interfacing effectively with Project Teams, Client Companies, and Investigators to ensure seamless SAE activities.Understanding assigned study-specific budgets and applying this insight to your work.Notifying expedited safety reports to Regulatory Authorities, Ethics Committees, and Principal Investigators within regulatory timelines.Providing project-specific safety training to PPD or equivalent experience Clinical for assigned projects.Performing detailed SAE/AE triage and ensuring accuracy in data entry, report tracking, and communication.Coding adverse event terms and drafting narratives according to client conventions.Assisting in the preparation and review of regulatory reports and processing adverse event reports from literature.Maintaining up-to-date knowledge of PPD and client SOPs and regulations.Communicating effectively with team members, client contacts, and adverse event reporters to successfully implement solutions.