Aggregate Safety Report (PSUR/PBRER/PADER) related activity
PSUR/PBRER/PADER and ACO scheduling and submission
Review and preparation of PADER/PSUR/PBRER, coordination for their submission as per their applicable dates
Handling of request received from central and local regulatory affairs and PV department with respect of timeline.

RMP Related activities
Assist in developing RMP and allied activities
Coordinate with Global team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates

Clinical Overview/Non-Clinical Overview (CO/NCO) Related activities
Assist in developing CO/NCO and allied activities
Coordinate with Global team as well as in-house reg team to ensure CO/NCOs are submitted as per their applicable dates

Signal management activities
Assist in CCDS/CCSI/RSI revision and issuance activities. Coordinate with reg team to ensure local label updates and managing tracking portal updates.
Ensure the maintenance of XEVMPD database and coordination with global team

📌 Spec, Ra Ahmedabad
🏢 Baxter India
📍 Ahmedabad