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Serialization Analyst

0-2 years
Not Disclosed
10 April 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

Company:
EVERSANA

Location:
Pune, Maharashtra, India

Function:
Information Systems / Serialization Compliance

Work Pattern:
Full-time


Job Description:
The Serialization Analyst supports serialization compliance activities under the Drug Supply Chain Security Act (DSCSA) regulations. The role involves direct collaboration with clients and their customers to ensure smooth implementation, testing, production support, and resolution of serialization and EPCIS data issues. The analyst will coordinate with internal and external stakeholders, handle XML/EPCIS files, and provide hands-on support with serialization solution providers such as Tracelink and Rfxcel.


Key Responsibilities:

  • Manage serialization integrations for DSCSA compliance, including EPCIS file handling.

  • Support DSCSA implementation, file generation, test execution, and production cutover.

  • Resolve shipment variances and regenerate corrected EPCIS files as needed.

  • Interface with EDI and IT teams for DSCSA electronic documentation (e.g., XML, AS2, sFTP).

  • Support and maintain documentation for serialization-related projects and activities.

  • Collaborate with external vendors and serialization software platforms.

  • Demonstrate inclusive behavior and commitment to diversity, equity, and inclusion.

  • Perform additional duties as assigned.


Qualifications:

Required:

  • Bachelor’s degree or equivalent experience.

  • Hands-on experience with EDI, XML, and EPCIS data.

  • Understanding of DSCSA regulatory requirements.

  • Experience with communication protocols such as AS2 and sFTP.

Preferred:

  • Familiarity with serialization platforms like Tracelink or Rfxcel.

  • Experience with Sterling Integrator is a plus.