Drug Safety Coordinator/ Sr. Drug Safety Associate

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.

The role:

The role
* 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.
* Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Clients' processes
* Serve as pharmacovigilance project manager, for both standalone and full service clinical study and post marketing projects, being clients first point of contact

* Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
* Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues
* Lead project team meetings and teleconferences as required
* Serve a resource for client/ investigational sites and ICON personnel on safety- related issues
* Liaise with Client and lead Client meetings, as required
* Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety Issues
* Liaise with ICON project manager, and other departments, as appropriate
* Identify out of scope activities in conjunction with the MSS Functional Lead
* Train/mentor newly hired DSA staff, as requested
* Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits/inspections), miscellaneous project activities)
* Generate study specific procedures for contracted departmental services
* Manage weekly and monthly project status reports

* Complete project oversight including resource, risk management, financial oversight, project health review.

* Assist with generation of regulatory reports as necessary to ensure regulatory compliance.
* Conduct safety presentations for start-up meetings, Investigator meetings and other meeting serve as PV Project manager on all (including global) medical or safety projects as assigned
* Actively identify out of scope activities in conjunction with the MSS Functional Lead and/or Clinical Project Manager
* Assist the MSS Functional Lead (e.g. Medical Monitor) independently

*Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures

* Perform safety review of clinical and diagnostic data
* Perform other activities as identified and requested by management

You will need:
* The successful candidate will have significant relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with thorough knowledge of global safety processes/regulations and medical terminology/coding systems.
* Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.
* Medical/science background (nursing preferred) and/or bachelor's degree or local equivalent.

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.