Specialist, Regulatory Affairs (Baxter)

Roles and Responsibilities

Aggregate Safety Report (PSUR/ PBRER/ PADER) related activity
- Responsible to provide PV support for new submissions and Post approval activities for Pharma Segment
- RFI Evaluation, Authoring Support activities (ASG) for PSUR/ PBRER/ PADER and ACO scheduling and submission
- Review and preparation of PADER/ PSUR/ PBRER, coordination for their submission as per schedule
- 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 RMP team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates

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
- Designation of New RSI and CCDS /CCSI Generation
- CCDS/ CCSI/ RSI Revision based on safety signals
- CCDS/ CCSI Periodic Review
- Local Label Updates based on RSI Revision

The Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
- Ensure the maintenance of XEVMPD database and coordinate for the entire Pharma segment
- EV codes monitoring based on any updates and New EV code generation based on products Approval.
- Fluxguard Monitoring for Generic labels globally