Spec, RA

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