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Baxter India Pvt Ltd

Spec, RA

Fresher

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  • Posted 8 months ago

Job Description

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

More Info

Job Type:
Industry:
Employment Type:
Open to candidates from:
Indian

About Company

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
For us, working at Baxter is not just a job—it’s a calling. Our mission to save and sustain lives unites us.
We are driven not by what will be easy, but what will transform global healthcare for generations to come. Together, we create a place where we are happy, successful and inspire each other as we pursue rewarding careers.
We’re grateful you’re interested in continuing your career journey with Baxter. This is where your purpose accelerates our mission and make a positive impact on millions of people around the world.

Job ID: 107338807