Baxter Hiring Specialist Regulatory Affairs (Pharmacovigilance) - Ahmedabad
Are you seeking high-paying Baxter Regulatory Affairs Jobs or Pharmacovigilance Careers in Ahmedabad? Global healthcare leader Baxter has announced an exciting vacancy for a Specialist, Regulatory Affairs (RA) at its Ahmedabad, Gujarat facility. Candidates with 3 to 5 years of experience in pharmacovigilance, aggregate safety reporting, and labeling compliance are encouraged to apply.
This role offers an exceptional opportunity to manage global post-marketing safety documentation, coordinate risk management plans, and maintain regulatory compliance. To prepare your application documents effectively, refer to our tutorial on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particulars | Details |
|---|---|
| Position | Specialist, Regulatory Affairs (Pharmacovigilance) |
| Company | Baxter |
| Location | Ahmedabad, Gujarat, India |
| Employment Type | Full-Time |
| Department | Regulatory Affairs & Pharmacovigilance |
| Experience Required | 3 - 5 Years |
| Qualifications | B.Pharm, M.Pharm, Pharm.D, M.Sc Life Sciences, or other relevant Life Sciences degrees |
| Application Deadline | June 30, 2026 |
| Job ID | JR-204717 |
| Estimated Salary | ₹8,00,000 – ₹15,00,000 per annum (Based on market trends) |
💼 Key Responsibilities
1. Aggregate Safety Report Activities
- Support pharmacovigilance operations for new regulatory submissions and post-approval pharmaceutical products.
- Review and prepare crucial regulatory safety reports, including Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and Periodic Adverse Drug Experience Reports (PADER).
- Manage authoring support activities under the Aggregate Safety Governance (ASG) framework.
- Coordinate safety report submissions in accordance with strict global regulatory timelines.
- Address requests and queries from global and local Regulatory Affairs and Pharmacovigilance teams.
2. Risk Management Plan (RMP) Activities
- Assist in the development, maintenance, and revision of Risk Management Plans (RMP).
- Coordinate activities with global RMP teams and internal regulatory stakeholders.
- Ensure timely and compliant submission of RMP documentation.
3. Clinical Overview (CO) & Non-Clinical Overview (NCO) Activities
- Support the preparation and submission of CO/NCO documentation for product registrations.
- Coordinate documentation reviews with global regulatory stakeholders and monitor compliance timelines.
4. Signal Management & Reference Safety Information (RSI)
- Identify and manage new Reference Safety Information (RSI) based on safety data evaluations.
- Develop, revise, and conduct periodic reviews of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI) documents.
- Support local label updates based on safety signal evaluations.
5. XEVMPD Database Management
- Maintain and update the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) database.
- Monitor EudraVigilance (EV) code updates and approvals, and generate new EV codes for approved products.
- Support global label monitoring using specialized tools like Fluxguard systems.
Writing aggregate safety reports requires a deep understanding of safety data. To build your conceptual knowledge, review our list of the Top 100 Entry Level Pharmacovigilance Questions.
🎓 Qualifications & Experience Requirements
Candidates applying for this specialist position should possess the following background:
- Degrees: B.Pharm, M.Pharm, Pharm.D, M.Sc in Life Sciences, or other relevant Life Sciences qualifications.
- Experience: 3 to 5 years of professional experience in Regulatory Affairs or Pharmacovigilance roles.
- Prior experience with aggregate reporting (PSUR/PBRER) and safety database tools is highly preferred.
For pharmacy graduates evaluating career options and compensation differences globally, read our detailed comparison on B.Pharm Career: India vs USA.
Required Core Skills
- Expertise in Regulatory Affairs and Pharmacovigilance compliance guidelines.
- Proficiency in authoring PSUR, PBRER, and PADER reports.
- Understanding of Risk Management Plans (RMP) and Signal Detection methodologies.
- Experience in CCDS/CCSI development and XEVMPD database management.
- Knowledge of labeling compliance, global regulatory submissions, and safety data analysis.
💰 Salary & Growth Prospects
- Estimated Compensation: ₹8,00,000 – ₹15,00,000 per annum (depending on qualifications, skills, and experience).
- Collaborate with global regulatory affairs and safety teams across multiple countries.
- Build hands-on expertise in international pharmacovigilance regulations.
- Work on critical patient safety initiatives at a leading multinational healthcare company.
To learn how pharmacovigilance and drug safety salaries scale across different regions, check our analysis on Pharmacovigilance Salary: India vs USA.
🌟 Why Join Baxter?
- Baxter is a globally recognized healthcare leader operating since 1931, dedicated to saving and sustaining lives.
- The company promotes a strong culture of innovation, collaboration, professional growth, and patient compliance.
- Excellent environment to expand expertise in aggregate safety reporting, labeling, and signal management.
If you want to compare pharmacovigilance operations with healthcare IT careers, read our comparison on Healthcare IT vs Clinical Healthcare.
📑 Resume Tips for Baxter RA Vacancies
- Clearly specify your experience in aggregate reporting (PSUR, PBRER, PADER) and the databases you have used.
- Highlight any experience with CCDS/CCSI development, signal management, and XEVMPD.
- Ensure your CV is well-structured and uses clear headings to remain ATS-friendly.
🎯 Baxter Specialist Regulatory Affairs Interview Questions
- What is the difference between a PSUR (Periodic Safety Update Report) and a PBRER (Periodic Benefit-Risk Evaluation Report)?
- Explain the role of the XEVMPD database in European pharmacovigilance.
- How is a safety signal evaluated, and what steps are involved in updating the CCDS/CCSI?
- What are the core components of a Risk Management Plan (RMP)?
- How do you prioritize multiple safety report submissions under tight regulatory deadlines?
📌 How to Apply?
Interested and eligible candidates can submit their applications online directly through Baxter's official Workday job board. The deadline to apply is June 30, 2026. For step-by-step guidance on setting up your Workday application profile, read our guide on how to apply for healthcare and pharma jobs online.
🚀 Apply Now
Apply Online❓ Frequently Asked Questions
Q. What is the application deadline?
The application deadline is June 30, 2026.
Q. What qualifications are preferred?
B.Pharm, M.Pharm, Pharm.D, M.Sc in Life Sciences, or other relevant qualifications.
Q. Where is this position based?
This is a full-time position located in Ahmedabad, Gujarat, India.
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