Baxter Hiring for Submission Analyst
About Baxter
Baxter is a global leader in innovative medical products and therapies, providing life-saving solutions to hospitals, clinics, and homes worldwide. With over 85 years of pioneering advancements, Baxter is committed to improving healthcare outcomes and saving lives. Join a team that contributes to healthcare excellence on a global scale. Baxter Hiring for Submission Analyst
Job Details
- Position: Submission Analyst
- Location: Bengaluru, India
- Experience Required: Minimum 1 Year
- Salary Range: ₹4.5–5.5 LPA
- Education Required:
- B.Pharm, M.Pharm, Pharm.D
- BSc, MSc, or Life Sciences degrees
Key Responsibilities
Regulatory Reporting
- Create and issue Individual Case Safety Reports (ICSRs) to regulatory authorities and business partners.
- Monitor electronic submissions to ensure compliance with global regulations.
Database Maintenance
- Set up and maintain electronic submission rules and product-specific reporting guidelines in the pharmacovigilance database.
- Provide submission intelligence to ensure accurate adverse event data coding.
Troubleshooting & Compliance
- Address and resolve E2B rejections and make necessary corrections for regulatory acceptance.
- Collaborate with regional pharmacovigilance teams to ensure seamless data distribution.
Collaboration
- Work closely with Safety Operations, IT, Regulatory, and Quality Assurance teams.
- Support global safety database management while adhering to safety standards.
Continuous Improvement
- Identify and escalate potential safety or compliance issues proactively.
- Participate in peer reviews and additional projects to improve efficiency and compliance.
Qualifications
Educational Background
- Required: Bachelor’s or Master’s degree in Computer Science, Life Sciences, or a related field.
Professional Experience
- Minimum 1 year of experience in pharmacovigilance, regulatory affairs, safety submissions, or clinical research.
- Additional experience in quality assurance, data management, or IT is beneficial.
Technical Skills
- Proficiency in pharmacovigilance terminology (ICH E2B).
- Familiarity with global safety databases and submission processes.
- Strong analytical and problem-solving skills.
Soft Skills
- Excellent organizational skills with attention to detail.
- Strong written and verbal communication abilities.
Why Join Baxter?
- Be part of a company dedicated to saving and sustaining lives.
- Engage in cutting-edge pharmacovigilance practices.
- Work within a collaborative and innovative environment that values continuous learning.
How to Apply
Submit your application online via Baxter’s official career portal. Join a team that’s making a difference in global healthcare every day! Baxter Hiring for Submission Analyst
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