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).