- sessments in trackers and liaise with Global Safety Officer (GSO) and PV Scientist for any flagged signals
- Maintain Literature Search Alert Tracker and ensure timely updates
SMART Meetings Management
- Schedule and organize SMART meetings with stakeholders
- Draft, compile, and distribute SMART reports in B-EAMS
- Host meetings, document review findings, address QC comments, and route final reports for approval
- Update the Safety Surveillance and Aggregate Reports (SSA) tracker with relevant data
SST Meetings Management
- Schedule and coordinate SST meetings
- Compile SST slide decks and prepare meeting minutes using standard templates
- Distribute finalized minutes and update SSA tracker
Compliance & Governance
- Ensure all signal management activities follow SOPs, job aids, and guidelines
- Escalate any delays in inputs, review comments, or endorsements
- Archive supporting documents in SharePoint or electronic repository according to defined timelines