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Serialization Analyst

2+ years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: Bachelor’s degree in a relevant field or equivalent experience. 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

Job Title:

Serialization Analyst

Location:

Pune, Maharashtra, India

Job Type:

Full-Time

Department:

Consultants

Job Family:

Information Systems


Company Overview

At EVERSANA, we are proud to be certified as a Great Place to Work® across the globe. Our mission is to create a healthier world by delivering next-generation commercialization services to the life sciences industry.

We support over 650 clients, from biotech start-ups to established pharmaceutical companies, with a global team of 7,000+ employees. Our solutions span across bringing therapies to market and ensuring patients get the support they need.

We’re building a diverse and inclusive culture driven by innovation, integrity, and a patient-first mindset. Join us and be part of a purpose-driven team making an impact every day.


Position Summary

The Serialization Analyst plays a key role in supporting compliance with the Drug Supply Chain Security Act (DSCSA) for U.S.-based pharmaceutical supply chains. This includes:

  • Managing serialization integration projects

  • Supporting EPCIS-based file formats

  • Coordinating directly with clients and customers

  • Handling ongoing serialization support and documentation

The role demands a blend of technical knowledge (EDI, EPCIS, XML) and strong client communication skills, with a focus on data exchange integrity and regulatory compliance.


Key Responsibilities

🔍 Serialization Support

  • Act as the primary contact for clients and customers regarding DSCSA serialization integrations.

  • Support the implementation and testing of EPCIS file formats and help transition to production.

  • Resolve and revise EPCIS files to address shipment discrepancies.

  • Collaborate with the EDI team to ensure accurate and compliant DSCSA documentation.

💼 Project Coordination & Issue Resolution

  • Support day-to-day serialization operations.

  • Manage and maintain project documentation.

  • Coordinate with vendors and tech teams to troubleshoot and implement serialization-related projects.

  • Analyze open issues and identify effective solutions.

🧠 Technical & Regulatory Knowledge

  • Maintain a strong understanding of:

    • Drug Supply Chain Security Act (DSCSA)

    • Electronic Product Code Information Services (EPCIS)

    • XML-based data exchange

  • Preferred knowledge of serialization platforms like TraceLink, Rfxcel, or similar.

  • Assist with FDA compliance documentation where needed.

🤝 Collaboration & Communication

  • Ensure clear communication between clients, internal teams, and external vendors.

  • Uphold EVERSANA’s commitment to diversity, equity, and inclusion by modeling inclusive behaviors and actively managing bias.

  • Perform all other duties as assigned.


Qualifications

🎓 Education

  • Bachelor’s degree in a relevant field or equivalent experience.

🧩 Required Skills & Experience

  • EDI experience is required.

  • Experience with EPCIS and XML file formats strongly preferred.

  • Familiarity with file transfer protocols such as AS2, sFTP, etc.

  • Experience with Sterling Integrator is a plus.

💬 Soft Skills

  • Strong communication skills (written and verbal).

  • Excellent problem-solving and analytical abilities.

  • Ability to work independently and in cross-functional teams.


Work Environment

  • Location: Pune, India (Remote flexibility may be applicable)

  • Travel: Minimal

  • Working Hours: Standard business hours with occasional extended support depending on project needs


Diversity & Inclusion

From our inception, Diversity, Equity & Inclusion (DE&I) have been foundational to our success. We welcome individuals of all backgrounds and identities. We believe that inclusive teams make better decisions and deliver better results.

EVERSANA is an Equal Opportunity Employer.


Recruitment Fraud Alert

Beware of fraudulent job offers misrepresenting EVERSANA. We do not request payment or sensitive personal information during our hiring process. If in doubt, apply directly via our official careers page.


Apply Now

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