Senior Analyst Engineer II

CHENNAI (IN)HYBRIDPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONICON PLCTechnology
ICON plc

ROLE DEFINITION & RESPONSIBILITIES

Core Responsibilities

Safety Application & System Support: Deliver technical and application support for Pharmacovigilance and Safety Services systems, primarily Oracle Argus Safety and related safety databases. Oversee user account maintenance, product configuration, study setup, license configuration, and codelist management.
Data Listings & Aggregate Safety Extraction: Extract and generate validated standard safety line listings from Argus to support DSURs, PBRERs/PSURs, 6-monthly line listings, and business partner data exchanges. Produce ad-hoc non-validated data extractions for internal cross-functional stakeholders.
E2B Troubleshooting & Global Transmission: Investigate and resolve technical transmission failures during E2B(R2/R3) import, export, and partner exchanges. Ensure compliant ICSR and aggregate safety data reporting to global health authorities and partner networks.
Release Management & IT Governance: Provide technical/functional assistance in system configuration, patching, and release deployments. Maintain alignment with IT governance, data privacy policies, and system access security controls.
Audit & Inspection Readiness: Support rapid-turnaround safety data requests and listings during internal quality audits and regulatory inspections.

Technical & Domain Standards

Strong command of safety database schemas, SQL/PL-SQL queries, and data extraction frameworks.
Adherence to global pharmacovigilance standards, GAMP 5 computer system validation concepts, MedDRA, WHODrug dictionaries, and E2B electronic submission standards.

Benefits & Total Rewards

Comprehensive healthcare and wellbeing plans (medical, dental, vision).
Performance-driven annual incentives, retirement/pension benefits, life and disability coverage, and structured global career pathways.

REQUIRED VERIFIED SKILLS

Argus Safety
Pharmacovigilance
SQL
PL/SQL
E2B Transmission
Safety Data Listings
DSUR
PSUR/PBRER
MedDRA
WHODrug

COMPENSATION & REWARDS

7.0L - 13.0L per annum

ORGANIZATION CONTEXT & CULTURE

ICON plc is actively hiring for this position.

INDUSTRY: Technology

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