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. Key Accountabilities/Responsibilities: Global oversight of safety risk management activities for assigned product(s) including clinical safety, signal detection, signal management, aggregate reports, risk communication, risk mitigation and risk management. Accountability to lead, in a cross-functional structure. Lead the development and maintenance of benefit risk assessments, safety risk management strategies and safety signal detection and assessment activities for assigned products. Providing strategic safety leadership for assigned product(s) across various cross-functional teams and governance bodies (e.g. Safety Review Committee). Collaborating with stakeholders within the company(e.g. Regulatory Affairs, QPPV, clinical development) and outside of the company (e.g. Key Opinion Leaders and regulators) to ensure the safe use of company products. The patient safety forproducts/compounds and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of PV Assessment activities through product development, product maintenance and life cycle management. Representing all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and reporting back relevant information regarding status, issues, challenges. Accountability and leading, in a matrix structure, the Benefit and Risk activities and ensuring signal detection, risk management, mitigation plans, safety analyses in aggregate reports. As well as scientific review of safety related information within in time lines and accuracy of the safety information in responses to Health Authorities, product labelling and investigator brochures. MD/DO/PhD/PharmD qualification or the equivalent. Substantial experience within the pharmaceutical industry. Along with a good understanding of the global pharmacovigilance and safety requirements for the registration process and onto the market with minimum 7 years of relevant experience. Strong personal leadership and communication skills and the ability to lead a multifunctional team. Strong scientific and analytic skills with an ability to provide interpretation and an assessment of complex data. Good knowledge of relevant regulations and proven evidence of effective delivery of high quality documents as well as relevant concepts in data management and systems, epidemiology and statistics. Ability to act without oversight in most circumstances as well as provide key input to difficult or sensitive projects. The technical skills and capabilities to author and contribute to large complex documents within document management systems and the knowledge of relevant concepts in pharmacovigilance. Be able to identify risks and propose corrective actions in complex and critical situations and the ability to a multifunctional team as well basic project management skills to allow management and delivery of multiple complex deliverables within tight timelines. Have a good knowledge of GVP and relevant legislations and guidelines. 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.