Global Safety Systems Specialist (Contractor)

The Steely Group; Boston (MA); On-site; USD 96,000 - 145,000; Full time

Job summary

The Steely Group is seeking a Contractor, Safety Systems to support Global Safety Systems administration, configurations, user access, and reporting rules, with a strong understanding of pharmacovigilance and Oracle Argus.

In this role you will lead onboarding/offboarding for PV vendors, configure studies and licenses, troubleshoot issues, and develop data queries and reports to support safety operations and regulatory compliance.

Qualifications

• 8+ years of safety systems experience (e.g. Argus/Aris/Veeva) in maintenance, interface and reporting tools
• Bachelor/Advanced degree in life science or healthcare field
• Strong project management and stakeholder communication skills
• Good understanding of pharmacovigilance practices and regulatory standards

Responsibilities

• Maintain and configure Global Safety Systems including code lists, libraries, reporting rules and data validations
• Onboard/offboard PV vendors and manage access to PV SharePoint sites and distributions lists
• Lead safety systems projects, system upgrades and configurations
• Create queries/reports to support PV needs (aggregate, signal, study, ad hoc reports)
• Troubleshoot safety systems issues and coordinate with vendors for resolutions

Skills

Safety Systems

Pharmacovigilance

Project management

Customer service

Communication skills

SQL

Education

Bachelor's or advanced degree in life science

Tools

Argus

Aris Global

Veeva

IQVIA PVQ

RxLogix PVR

Job description

The Steely Group is seeking a Contractor, Safety Systems to support Global Safety Systems administration, configurations, user access, and reporting rules, with a strong understanding of pharmacovigilance and Oracle Argus.

In this role you will lead onboarding/offboarding for PV vendors, configure studies and licenses, troubleshoot issues, and develop data queries and reports to support safety operations and regulatory compliance.