Serialization Associate (DSCSA / EPCIS / TraceLink)

EVERSANA; Pune District; Sur place; INR 500 000 - 700 000; Plein temps

Résumé du poste

EVERSANA is looking for a Serialization Associate in Pune, India. You will be responsible for investigating and resolving compliance exceptions in the pharmaceutical domain, ensuring serialization events' accuracy. The role demands strong analytical skills and effective communication abilities, operating within a fast-paced environment.

Min. 1–2 years in serialization or supply chain compliance is required, with hands-on experience in EPCIS file formats. Join us to help improve patient lives through excellence and innovation.

Qualifications

• 1–2 years of experience in pharmaceutical serialization or supply chain compliance.
• Hands-on experience with EPCIS file formats and GS1 standards.
• Ability to work on US Central Time shift.

Responsabilités

• Investigate and resolve EPCIS file failures.
• Validate commission events and aggregation hierarchies.
• Document all exceptions and resolutions in ServiceNow.

Connaissances

EPCIS file formats

DSCSA operations

Strong analytical skills

Effective written communication

Outils

TraceLink

rfxcel

Systech

SAP ATTP

ServiceNow

Description du poste

Job Description

As a Serialization Associate, you will serve as a front-line execution specialist responsible for investigating, resolving, and documenting DSCSA compliance exceptions across our pharmaceutical 3PL client portfolio. Working in a fast-paced, 24x6 support environment, you will own ticket resolution from triage to closure — ensuring serialization events are accurate, compliant, and fully traceable.

DSCSA Transaction & Exception Handling

• Investigate and resolve EPCIS file failures including schema errors, master data mismatches, and event sequence violations
• Validate commission events, aggregation hierarchies (SSCC to Case to Each), shipping/receiving confirmations, and returns verification events
• Review inbound and outbound EPCIS transactions for accuracy prior to retransmission
• Identify and correct mismatches in SGTIN/SSCC, GLN/SGLN, lot/expiry data, and business step inconsistencies
• Document all exceptions and resolutions in ServiceNow with sufficient detail for audit purposes

Serialization Lifecycle Execution

• Apply working knowledge of the full DSCSA event lifecycle: Commission, Pack/Aggregate, Ship, Receive, Return, and Destroy
• Validate aggregation integrity before authorizing outbound shipment events
• Troubleshoot serialized returns and product status discrepancies across trading partners
• Support reprocessing and retrigger strategies for failed or rejected events

Platform & Repository Troubleshooting (L4 Systems)

• Work within serialization platforms including TraceLink, rfxcel, and Systech
• Identify and resolve common repository rejections: duplicate commissioning, invalid aggregation structures, missing transaction identifiers
• Collaborate with senior team members on complex platform-level issues requiring configuration review

Regulatory Compliance Awareness

• Maintain working knowledge of DSCSA Section 582 requirements, product tracing/verification obligations, and serialized returns saleable verification workflows
• Understand suspect/illegitimate product investigation triggers and escalation protocols
• Ensure all activities align with GS1 standards and DSCSA regulatory requirements

Operational Excellence & Ticket Management

• Respond to assigned tickets within defined SLAs — no silent aging
• Maintain full incident ownership through resolution with structured handoff documentation
• Escalate systemic trends, recurring failure patterns, or compliance-at-risk items to the Project Leader
• Participate in shift handoffs with concise, structured status communication

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

• 1–2 years of experience in pharmaceutical serialization, DSCSA operations, or supply chain compliance
• Hands‑on experience with EPCIS file formats and GS1 standards (SGTIN, SSCC, GLN, BizStep)
• Familiarity with serialization platforms such as TraceLink, rfxcel, Systech, or SAP ATTP
• Experience in ITSM environments — ServiceNow preferred
• Strong analytical skills with close attention to regulatory detail
• Effective written communication for cross‑functional audiences
• Ability to work on US Central Time shift

Preferred Qualifications

• Experience supporting a pharmaceutical 3PL or wholesaler (McKesson, AmerisourceBergen, Cardinal) in a serialization capacity
• Exposure to WMS platforms (SAP WM/EWM or similar) and their interaction with serialization systems
• Understanding of DSCSA Section 582(d) 3PL‑specific obligations
• GS1 Healthcare or DSCSA‑related certification
• ITIL‑based service management experience

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.