Submission Analyst

0-2 years

Not Disclosed

Bangalore

10 Dec. 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Submission Analyst - Baxter
Req # JR - 149815
Location: Bengaluru, Karnataka, India
Job Category: Patient Safety
Date Posted: 12/02/2024

About Baxter:

At Baxter, we are deeply connected by our mission of saving and sustaining lives. For over 85 years, we have been pioneers in medical innovations that positively impact patient outcomes worldwide. Our products and therapies are found in hospitals, clinics, and homes globally. At Baxter, you’ll feel the purpose of your work and experience an environment where success and happiness thrive. Join us at the intersection of life-saving care and innovative healthcare solutions.

Position Summary:

The Submission Analyst is part of the Safety Submissions team within Global Pharmacovigilance. This role involves managing the electronic distribution and submission of Individual Case Safety Reports (ICSRs) to regulatory authorities, affiliates, or business partners, and maintaining electronic submission rules within the pharmacovigilance database.

Essential Duties and Responsibilities:

Create and issue regulatory reports, including ICSRs.
Run and monitor electronic submissions of ICSRs to regulatory authorities, affiliates, and business partners.
Participate in peer review of submissions from team members.
Set up and maintain electronic submission rules and reportability by product and recipient in the pharmacovigilance database.
Provide electronic submission intelligence to Safety Operations to ensure proper coding of adverse event (AE) data.
Assist in troubleshooting E2B rejections to ensure compliance with applicable regulatory agencies.
Collaborate with various functions including regional pharmacovigilance teams, data analysts, and other departments to facilitate electronic distribution and submission.
Prioritize and escalate safety/compliance issues as needed.
Perform additional responsibilities and projects as assigned.

Qualifications:

Knowledge of pharmacovigilance terminology, especially ICH E2B, and system data entry conventions.
Strong problem-solving and analytical skills.
Attention to detail and strong organizational skills.
Excellent written and oral communication skills.
Experience with Global Safety Databases and solid technical system skills (e.g., word processing, spreadsheets, databases).
Knowledge of medical terminology is a plus.

Education and Experience:

Bachelor's degree in Computer Science, Life Sciences, or equivalent.
At least one year of experience in Safety Submissions, pharmacovigilance, regulatory affairs, or clinical research is desired.
Additional experience in quality assurance, data management, or IT is beneficial.

Additional Information:

Baxter is committed to providing reasonable accommodations for individuals with disabilities throughout the application process. Please contact us if you need accommodations for any part of the application or interview.

Recruitment Fraud Notice: Baxter has discovered employment scams where fraudulent parties pose as Baxter employees to steal personal information. Please review our Recruitment Fraud Notice to learn how to protect yourself.

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Submission Analyst

Job Description

About Baxter:

Position Summary:

Essential Duties and Responsibilities:

Qualifications:

Education and Experience:

Additional Information:

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