Drug Safety Specialist

• 5+ years experience in Pharmacovigilance/Safety IT or supporting GxP-regulated life sciences systems.
• Hands‑on experience supporting PhV Systems (like Veeva Vault Safety in production), including troubleshooting and configuration.
• Experience with validated environments (CSV/GxP), including change control and documentation.
• Ability to support workflow/lifecycle configuration, user access management, and periodic release testing.
• Strong understanding of PV processes, safety case lifecycle, and regulatory expectations.
• Experience supporting or interacting with Argus Safety (functional or L2/L3 support).
• Strong communication skills and comfort working directly with business users.

• Project Management experience in pharma IT.
• Experience with system integrations (APIs, SFTP, ETL/middleware).
• Experience resolving issues related to case processing workflow, reporting, or data flow in safety systems.
• Experience providing documentation for audits or inspections.
• ITIL experience (incident, problem, change management).

We are seeking an IT Pharmacovigilance (PV) Systems Analyst with strong experience supporting Veeva Vault Safety in a GxP-regulated environment. This role is primarily focused on L2/L3 run and support, ensuring the stability, compliance, and daily operation of Veeva Vault Safety and, secondarily, Oracle Argus Safety. The ideal candidate has hands‑on experience troubleshooting issues, managing validated change control, supporting periodic releases, and working closely with PV Operations, Regulatory, Clinical, Quality, and IT QA teams.

This is an onsite, long‑term role supporting critical global safety systems.

• Assist with the Project Management of the technical rollout of Veeva Safety.
• Provide L2/L3 production support for Veeva Vault Safety, handling incidents, service requests, and system issues.
• Troubleshoot workflow, lifecycle, user access, data, configuration, and integration issues.
• Perform light configuration updates (objects, fields, workflows, life cycles, permissions, notifications).
• Conduct release impact assessments and support regression testing during Veeva’s continuous release cycles.
• Maintain system documentation, audit trails, SOPs, and support evidence as required for inspections.

• Support Argus Safety system incidents, configuration updates, and case processing workflow issues.
• Assist with E2B reporting troubleshooting, dictionaries (MedDRA/WHO Drug), and reconciliation activities.

• Execute changes under GxP-compliant change control, including impact assessments; test scripts and UAT support; documentation of validation evidence; and coordination of approvals and releases.

• Monitor and troubleshoot integrations between Vault Safety, Argus, and downstream/partner systems like RxLogis and PSIXChange.
• Support reconciliation processes, interface error handling, and data quality investigations.
• Assist in generating or maintaining safety system operational reports and dashboards.

• Partner closely with PV Operations, Clinical, Regulatory, QA, CSV and IT teams.
• Communicate status updates, issue resolution, risks, and timelines clearly and professionally.
• Participate in user support activities, periodic access reviews, and training as needed.

$70/hr to $78/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.