Technical Configuration & Business Logic :

- Design, implement, and maintain technical configurations workflows, case processing rules, expedited and periodic reporting rules, user groups and roles, site and org hierarchies, interfaces, and scheduled jobs.

- Lead business configuration codelists, flexible re-categorization, MedDRA and WHO-Drug dictionary uploads and versioning, letters and templates, advanced conditions, and console-level settings.

- Own product configuration parent/child licensing, investigational vs. marketed status, combination products, biosimilars, and license-country mappings aligned to each client's regulatory footprint.

- Own study configuration for interventional trials, observational studies, and registries including single-blind, double-blind, and open-label studies.

- Design, execute, and document controlled unblinding workflows in safety systems in compliance with protocol, SOPs, and regulatory expectations (FDA IND safety reporting, EMA CT Regulation 536/2014, ICH E6(R3)).

- Ensure role-based access controls, segregation of duties, and full audit traceability for blinded treatment information and emergency unblinding events.

- Partner with PV Operations leads to translate business requirements into configuration specifications, impact assessments, and test scripts.

Incident Management & Service Operations :

- Serve as the senior escalation point for safety system incidents, defects, and service requests across client accounts.

- Own ticket triage, root-cause analysis (RCA), workaround design, and permanent-fix coordination within defined SLAs; drive continuous-improvement plans on recurring issues.

- Conduct weekly and monthly service reviews with client IT, PV Operations, and QA stakeholders; present KPIs on ticket volumes, MTTR, CAPAs, and system health.

- Define and evolve runbooks, knowledge-based articles, and standard operating procedures for L1/L2 teams to drive self-sufficiency.

- Ensure adherence to ITIL-aligned incident, problem, change, and release management processes across all supported client estates.

Technical & Domain Expertise :

- Strong grounding in pharmacovigilance regulatory definitions (AE/SAE/SUSAR), expectedness, causality, seriousness, and listedness assessments.

- Deep, hands-on expertise with at least two of: Oracle Argus Safety (7.x/8.x), ArisGlobal LifeSphere Safety / agXchange, Veeva Vault Safety. Willingness and ability to work platform-agnostic across client estates.

- Demonstrated experience across the full lifecycle: implementation, go-live, hypercare, steady-state managed services, upgrades, and decommissioning.

- Strong, hands-on proficiency in SQL and PL/SQL able to write complex queries, analyse execution plans, and debug procedures directly in safety systems, comfortable reading and interpreting database schemas independently.

- Familiarity with middleware and integration patterns (APIs, web services, gateways, ESBs) and with database administration concepts relevant to PV platforms.