Specialist, RA (Baxter)

Roles and Responsibilities

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

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