PV Safety Systems Analyst - Argus

Are you an expert when it comes to using ARGUS? If so we have a great opportunity to join our global team focussed on safety systems within Medical & Safety Services. The successful candidate will assist in technical consultation or support services for medical projects and colleagues on all system activities. Coordinate the existing safety system and contribute by developing, implementing, maintaining, troubleshooting and improving safety and tracking systems according to internal or external requirements. *LI-MB1

Job Functions / Responsibilities

• Accountable for developing, maintaining, troubleshooting and improving the company’s safety systems and project specific data tracking / maintenance tools
• Ensure all safety system activities are completed in accordance with SOPs, SSPs, WPs and other applicable regulations. Establish new SOPs, SSPs, WPs if needed.
• Responsible as System / Database Administrator for technical support, maintenance and continued development / implementation of systems and tools for internal and clients.
• Ensure proper documentation including  workflows for applications, tools, audit readiness and Medical & Safety Services representation at audits
• Generate and develop quality and performance metrics / KPIs on all processes as well as reports and analysis where safety systems are used
• Maintains and enhances technical knowledge in all relevant areas as well as in global developments
• Keep management aware of potential & actual issues. Assist developing solutions.
• Other activities as identified and requested by senior management
• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 10%) domestic and/or international
• Other duties as assigned

Supervision 

• Contribute in project teams involving Safety Systems including Client, IT and Vendor(s) liaison, and manage timelines as appropriate
• Provide internal and external training and identify training needs; provide Medical & Safety Services training to other departments as requested

Experience, Skills & Knowledge requirements:

• Has supported, or worked on projects for, a Pharmacovigilance system at a Pharma co, a CRO, or a related services company for 3 years or longer
• Experience (3 years plus) with either Argus Safety or ArisG as either an administrator/super-user, or on a technical basis
• Experience with working in a validated/GxP compliant environment
• Can demonstrate experience in at least one of the following - either with technical or business-level involvement:
• Analytics/ad-hoc reporting in Argus or ArisG
• Expedited reporting (especially E2b reporting to EMA or FDA)
• Periodic reporting (PSUR, DSUR, etc.)
• Supporting regulatory inspections or customer/supplier audits

Education requirements

• Bachelors Degree or local equivalent
• Masters degree desired but not essential

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development.  We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career.  We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. 

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.