GPS Safety Risk Management Lead

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.

Perform and support Global Patient Safety activities including signal detection, generation of aggregate reports and assist with the assigned activities of Global Medical Safety Leads (GSLs).

• Provides safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development)
• Assist GPS GSLs in their assessment of medical safety data for assigned products, development and execution of safety signaling and benefit-risk management strategies and closely collaborate with stakeholders internally
• Participate in safety and risk management processes including safety management teams and benefit-risk committees.
• Effectively oversee and participate in the planning, preparation and review of periodic reports (DSUR, PSUR, PADER
• Identify, prioritize and analyze clinical safety signals, in accordance with GPS procedures
• Perform ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources
• Participate in protocol development and review, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans, as needed
• Participate in the analysis of safety data from on-going and completed clinical trials for representation in Clinical Study Reports
• Review and provide safety input, as needed, for key study-related documents, e.g. Investigator’s Brochure (IB), Informed Consent Form (ICF), Independent Data Monitoring Committee (IDMC) Charter
• Participate in departmental development activities including SOP and Work Instructions development
• Perform other activities as needed to assist with departmental activities

• Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences or technical fields (Ph. D. or M.D a plus)
• Minimum of 3-5 years of relevant pharmaceutical/biotech industry or healthcare experience
• Pharmacovigilance/safety risk management experience is strongly preferred

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.

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.