Premier Research is looking for a Safety Systems Analyst Level 1 to join our Pharmacovigilance and Records Management team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll be Doing:
- Supports the design and implementation of system solutions for pharmacovigilance focused around the safety database and safety data distribution platform.
- Support the AD Safety Systems and global IT in the implementation of new PV systems and major systems upgrades, interfaces with external systems
- Acts as a SME for PV for integrations between PV systems and the rest of Premier’s IT infrastructure and architecture.
- Creatively contributes to system configuration and solution design.
- Supports the Safety operations Argus SMEs by acting as an escalation point for any technical issues regarding Premier’s Pharmacovigilance/safety systems that cannot be resolved by the first line Safety ops. SMEs.
- Takes ownership of issues and sees problems through to resolution and manages CAPAs to closure through the investigation of root causes, identification of corrective action and monitoring of the effectiveness of implemented process/system.
- Participate in PV Audits and Inspections
- Provide subject matter expertise to maintain systems training material and controlled documents in accordance with new systems releases •
- Contribute to new systems training materials and provide training to the appropriate subject matter experts
- Programs reports within the safety system using SQL and/or other programming languages
- Serves as a technical resource to the study teams for data visualization. KPIs and reporting tools
- Logs and tracks requests for metrics reporting using appropriate tracking tool
- Assists operations team and Head of PV with technical issues
What we are searching for:
- Bachelor degree, or international equivalent from an accredited institution, preferably in a technical field, or equivalent combination of education, training and experience
- 2 to 5 years of practical experience implementing, upgrading and enhancing commercial Pharmacovigilance Safety systems (eg. Oracle Argus, ArisG) and a thorough understanding of how to interpret business needs and translate them into application and operational requirements
- Experienced with GxP system validation, particularly requirement collection and User Acceptance Testing
- 1 to 2 years of SQL programming experience preferred
- Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
- Demonstrates excellent English verbal and written communication skills
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
- Technical skills and experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview) preferred
