Specialist, RA

Baxter View all jobs

  • Ahmedabad, Gujarat
  • Permanent
  • Full-time
  • 14 hours ago
This is where your work makes a difference.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 timelineRMP 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 datesCO/ 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 datesSignal 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 RevisionThe 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 globallyEqual Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Baxter