Medical Reviewer – Team Lead

conduct weekly literature review to identify potential safety signals and support aggregate report inclusion.

Record literature assessments in trackers and liaise with Global Safety Officer (GSO) and PV Scientist for signal evaluation.

Prepare summaries of articles of interest for SMART meetings.

Schedule and host SMART meetings, coordinate stakeholders, and draft SMART reports in the Electronic Data Management System (B-EAMS).

Document meeting discussions, action items, and ensure timely distribution and finalization of SMART reports.

Update Safety Surveillance and Aggregate Reports (SSA) tracker with relevant information.

Organize and coordinate SST meetings, prepare slide decks, document meeting minutes, and track action items.

Perform signal management activities in compliance with SOPs, job aids, and regulatory requirements (GVP, ICH-GCP).

Escalate delays or issues as per defined processes.

Archive supporting documentation in SharePoint or electronic repositories within defined timelines.

Respond to queries related to SMART reports within specified timelines.

Work with IT systems such as Tableau, BEAMS, and SharePoint as required.

Ensure completion of assigned training within timelines.