Drug Safety Manager

"At ICON, it's our People that set us Apart"

ICON plc, a leading global Contract Research Organization employing 15,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

About the Drug Safety Manager at ICON

* Serve as the main point of contact for the customer for the life-cycle of assigned stand-alone projects, and the main pharmacovigilance point of contact for assigned full-service projects

* Successful completion of projects on-time, within budget limits and with approved quality levels to support achievement of the department's overall financial and quality goals and objectives
* Management of assigned teams to ensure project and departmental deliverables are being met
* Ensure all assigned project and departmental activities are completed in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors

Roles & Responsibilities

* As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
* Travel (approximately 15%) domestic and/or international*.
* Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
* Serve as the main point of contact for the customer for the life-cycle of assigned stand alone projects, and the main pharmacovigilance point of contact for assigned full-service projects*
* Ensure the assigned project contracted tasks are completed according to project specific procedures and meet key metrics
* Oversee implementation of projects including client communications, project specific plans, system set-up, and establishment of appropriate and agreed-upon metrics*
* Completion of project status reports/review meetings including burn hours, profit margins, quality review findings and other metrics*
* Lead identification of out of scope activities and process efficiency/improvement needs or implement contract amendments/change orders as required *
* Coordinate and present at meetings (project and department) as required
* Support QPPV as required
* Develop and maintain excellent client relationships
* Assisting the Director/Senior Director to develop and grow capabilities, productivity, and quality levels.
* Actively participate in quality and training initiatives
* Participate in process improvement by actively identifying process improvements, developing better procedures, and working to additionally implement those change / process improvements
* Interview, evaluate and recommend new PVSS hires
* Train/mentor Drug Safety Coordinator and other Drug Safety Manager staff*
* Develop staff for succession planning, ie, develop next generation of management/leaders
* Coordination and participation in interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities)
* Participate in Business Development activities as requested
* Perform other activities as identified and requested by management

To succeed you will need:

A minimum of 10 -15 years relevant experience required including rich experience in post marketing safety experience preferably holding a manager position currently. Must have the qualification of MPharm/DPharm/Nursing/BPharm

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives. We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies

What's Next?

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

We invite you to review our opportunities at www.iconplc.com/careers.