Technical Owner - Pharmacovigilance & Regulatory Affairs (PV/RA) - UTSC3012

5+ years of experience in IT roles within the Life Sciences industry. At least 3 years in a Technical Owner, Application Manager, or Technical Lead role for Regulatory Affairs or Pharmacovigilance systems.

Regulatory Affairs:

ArisGlobal LifeSphere RIMS, Veeva Vault RIM, Freyr RIMS, Lorenz docuBridge, Ennov RIM, Rosetta Viewer, etc. Pharmacovigilance:

Oracle Argus Safety, Empirica Signal, etc.

Technical Skills: Experience with Oracle database concepts such as PL/SQL, database links (dblinks), triggers and data model management. Experience with other database technologies (e.g., SQLServer, PostgreSQL, Progress/OpenEdge) is a plus. Ability to query and interpret application data models to support reporting and troubleshooting. Familiarity with system architecture, APIs, and integrations in cloud-based and hybrid environments. Experience with GxP validation, data integrity, and compliance in a regulated environment. Good knowledge of ITIL processes and service management tools (ServiceNow preferred).