Icon plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. Icon people have a mission to succeed and a passion that ensures what we do, we do well.
Supervises group of drug safety associates (dsas), safety data coordinators (sdcs), safety assistants and other personnel within the drug safety center to provide services for serious adverse events (sae)/adverse reactions /medical device report management, periodic safety reports, and coding. Supports development of sops, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance.
Reviews dsa, sdc and/or safety assistant group-related project tasks; provides leadership in the delivery of related services to clients; ensures that staff fulfill their responsibilities in accordance with company policies, procedures, and
sops; creates an environment that encourages learning, self-improvement and career development for staff; supports the development and implementation of training for dsas, sdcs, safety assistants or other personnel within the drug safety center
- acts as a dsa, sdc or safety assistant on assigned projects.
- recommends and supports implementation of drug safety center performance and productivity improvements to ensure optimal utilization of billable staff; performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes; identifies and implements process improvements through review of sops, processes; recommend improvement plans to senior management; participates in task forces to implement process improvement initiatives; builds teamwork and improves process and productivity by working within and across functional areas
- develops company employees to ensure high quality work performance and retention of high quality employees; ensures staff development and performance feedback are provided through activities such as mentorship and career development; communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
- involved in the recruiting processes for new drug safety center employees.
- supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.
- supervises the follow-up of cases
undergraduate degree in clinical, science, or health related field from an accredited institution, or equivalent work experience required.
3 years of pharmaceutical or contract research organization experience in pharmacovigilance and/or
associated services required
read, write and speak fluent english
*benefits of working in icon*:
our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At icon, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Icon, including subsidiaries, 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.