Drug Safety Manager

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Are you interested in serving as the client's main point of contact for the entire life-cycle stand alone projects, and be the main safety reporting point of contact?

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 in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.