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Serialization Analyst

EDI (Electronic Data Interchange) experience is required years
Not Disclosed
10 Aug. 26, 2025
Job Description
Job Type: Full Time Education: Bachelor’s degree in a related 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
Department: Consultants
Job Family: Information Systems
Employment Type: Full-time


Company Overview

EVERSANA is a leading provider of next-generation commercialization services for the life sciences industry. With over 7,000 global employees, we serve more than 650 clients, from innovative biotech start-ups to global pharmaceutical leaders. Our work helps bring therapies to market and supports the patients who depend on them.

We are:

  • Certified as a Great Place to Work worldwide

  • Deeply committed to diversity, equity, and inclusion

  • Driven by our cultural beliefs centered around innovation, integrity, collaboration, and patient care

Join us in creating a healthier world.


Position Overview

The Serialization Analyst will support the implementation and maintenance of serialization processes to ensure compliance with the Drug Supply Chain Security Act (DSCSA) regulations in the U.S. You will work closely with clients, customers, and technology partners to support file exchanges, production integrations, and supply chain serialization activities, with a focus on EPCIS standards and XML-based data formats.


Key Responsibilities

Serialization & Regulatory Compliance

  • Serve as a primary contact for DSCSA serialization integration between clients and their customers

  • Support the generation, validation, and communication of EPCIS test files and production data for implementation

  • Troubleshoot and resolve shipment variances and assist in issuing corrected EPCIS files

  • Ensure timely support of electronic document exchange in collaboration with the EDI team

  • Support day-to-day serialization activities, including documenting workflows and ongoing projects

Project Coordination & Technical Collaboration

  • Coordinate with vendors and internal technology teams to manage serialization-related projects

  • Analyze and resolve technical issues related to serialization file structures, communication protocols, or partner integrations

  • Ensure compliance with regulatory standards, particularly DSCSA and EPCIS specifications

Other Duties

  • Actively promote and demonstrate diversity, equity, and inclusion (DEI) in daily work

  • Support various client requests or tasks as assigned


Qualifications

Education

  • Bachelor’s degree in a related field or equivalent experience

Required Experience & Skills

  • EDI (Electronic Data Interchange) experience is required

  • Strong working knowledge of XML file-based data exchange

  • Understanding of communication protocols such as AS2, sFTP, etc.

  • Familiarity with Sterling Integrator is a plus

  • Knowledge of DSCSA regulations and EPCIS standards is essential

  • Hands-on experience with serialization platforms such as Tracelink, Rfxcel, or other serialization solution providers is preferred


Key Competencies

  • Excellent problem-solving and analytical skills

  • Strong communication and interpersonal skills

  • Ability to work both independently and collaboratively in a fast-paced, regulated environment

  • Proficiency in Microsoft Office Suite and documentation tools


Work Environment & Culture

We thrive on a culture that promotes:

  • Patient Mindedness – Putting patient needs first

  • Client Delight – Owning every client experience

  • Taking Action – Empowering ourselves and others

  • Talent Growth – Fostering development and success

  • Winning Together – Collaborating with passion

  • Communication – Encouraging transparency and open dialogue

  • Diversity – Embracing all perspectives

  • Innovation – Driving bold, creative thinking


Equal Opportunity Employer

EVERSANA is proud to be an Equal Opportunity Employer, embracing diversity across all identities including age, disability, race, religion, sexual orientation, gender identity, and veteran status. We are committed to building an inclusive environment for all.


Important Notice: Recruitment Fraud

EVERSANA is aware of fraudulent job offers that misrepresent our brand. We never:

  • Ask for payment at any stage of the hiring process

  • Request sensitive personal data via unsolicited emails or third-party platforms

If you're in doubt, please verify through our official website.


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