Pharma Covigilence, Pharma Regulatory, SQL, ITIL
Experience:
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.
Proven experience with one or more of the following systems:
Regulatory Affairs: Aris Global Life Sphere RIMS, Veeva Vault RIM, Freyr RIMS, Lorenz docu Bridge, 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, Postgre SQL, Progress/Open Edge) 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 Gx P validation, data integrity, and compliance in a regulated environment.
Good knowledge of ITIL processes and service management tools (Service Now preferred).
Preferred Skills
Familiarity with data visualization and reporting tools such as Power BI.
Knowledge of integration frameworks and data exchange standards used in Regulatory and Safety domains (e.g., IDMP, E2 B, XEVMPD).
Experience with integration of Regulatory systems with other enterprise platforms (e.g., Document Management, Safety, or Quality systems).
Experience in cloud environments (AWS, Azure) and Dev Ops/automation concepts is an advantage.
Good understanding of the business processes in Regulatory Affairs and Pharmacovigilance domains (e.g., submission management, case processing, signal detection), sufficient to support reporting and data interpretation.
Functional knowledge is a strong plus but not mandatory, as the focus of the role is on the technical ownership and data model understanding