ICON Clinical Research Safety Systems Analyst in North Wales, Pennsylvania
- Safety Systems Analyst*
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The job holder provides technical expertise on a high level to ensure that projects using safety systems within Medical & Safety Services run efficiently, accurately and in accordance to ICON standards, regulatory requirements, and contractual obligations to clients. They will maintain and enhances technical knowledge in all relevant areas. Where appropriate the job holder provides or assists in technical consultation or support services for medical projects and colleagues on all system activities.
Overview of the Role*
Accountable for developing, maintaining , troubleshooting and improving the company's safety systems and project specific data tracking /I/ maintenance tool.
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 /I/ Database Administrator for technical support, maintenance and continued development /I/ 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 /I/ KPls 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 development.
Keep management aware of potential & actual issues. Assist developing solutions.
Essential Domain skills
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
Essential General skills
Excellent written and verbal communication (English)
Experience of international/global working environment
Benefits of Working in ICON*
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.
- What’s Next?*
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
- ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.*