Serialization Analyst

2+ years

Not Disclosed

Pune

10 Dec. 12, 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

Company Overview:

At EVERSANA, we are proud to be certified as a Great Place to Work globally. Our vision to create a healthier world drives us, and our global team of over 7,000 employees is dedicated to delivering next-generation commercialization services to the life sciences industry. Serving more than 650 clients—from innovative biotech startups to established pharmaceutical companies—we provide solutions that help bring groundbreaking therapies to market while supporting the patients who rely on them. Together, we make an impact every day.

We embrace diversity and are committed to improving patient lives worldwide. We believe people from all backgrounds are essential to shaping the future of healthcare. Our culture is inclusive, and we are deliberate about fostering a team that cares deeply about EVERSANA, our clients, and the patients we serve. We are EVERSANA.

Position: DSCSA Serialization Analyst
Location: [Insert Location]
Job Type: Full-time

Job Description:

The DSCSA Serialization Analyst plays a critical role in supporting the serialization of the pharmaceutical supply chain in compliance with the Drug Supply Chain Security Act (DSCSA). This position involves direct interaction with clients and customers to facilitate serialization integrations, testing, and production support for supply chain issues related to DSCSA compliance.

Key Responsibilities:

Client and Customer Interaction: Work directly with clients and customers to support serialization integration for DSCSA regulatory compliance.
Implementation Support: Assist with DSCSA implementation using various EPCIS file formats, including generating and communicating test files and supporting the transition to production.
File Management: Resolve and communicate revised EPCIS files to address shipment variances.
EDI Support: Collaborate with the EDI team to support DSCSA electronic documents.
Day-to-Day Serialization Support: Oversee ongoing serialization activities, document project progress, and support coordination with vendors and other teams.
Technology Integration: Coordinate the implementation of serialization projects and identify solutions for open issues.
Industry Knowledge: Maintain a background understanding of DSCSA and EPCIS, including experience with serialization solution providers like Tracelink and Rfxcel.

Job Expectations:

Diversity and Inclusion: Demonstrate commitment to diversity, equity, and inclusion through continuous development and inclusive behavior.
Problem Solving: Proactively manage project issues and find effective solutions.
Project Coordination: Manage documentation and coordinate efforts with vendors and other technology teams.

Qualifications:

Education: Bachelor’s degree or equivalent experience.
Experience: EDI experience is required; preference for candidates with EPCIS/XML experience and knowledge of AS2, sFTP, and other communication methods.
Technology/Equipment: Experience with Sterling Integrator is a plus.

Additional Information:

Fraud Prevention Notice:
Beware of fraudulent job offers misrepresenting EVERSANA. We will never request personal information or payment during the hiring process. If you encounter suspicious offers, please report them.

Diversity, Equity, and Inclusion:
EVERSANA is an Equal Opportunity Employer. We believe diversity is integral to our success, encompassing race, gender, age, disability, veteran status, sexual orientation, religion, and more. Inclusion is everyone's responsibility, and we value all employees' perspectives in improving patient lives and advancing healthcare innovation.

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Serialization Analyst

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