Safety Scientist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• 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 riskmanagement.
• Accountability to lead, in a cross-functional structure. Lead the development and maintenance ofbenefit risk assessments, safety risk management strategies and safety signal detection andassessment activities for assigned products.
• Providing strategic safety leadership for assigned product(s) across various cross-functional teams andgovernance 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 thePharmacovigilance regulations of Regulatory Agencies around the globe through the effective andtimely completion of PV Assessment activities through product development, product maintenanceand life cycle management.
• Representing all activities related to pharmacovigilance, clinical safety, risk management and signaldetection, and reporting back relevant information regarding status, issues, challenges.
• Accountability and leading, in a matrix structure, the Benefit and Risk activities and ensuring signaldetection, risk management, mitigation plans, safety analyses in aggregate reports. As well as scientificreview of safety related information within in time lines and accuracy of the safety information inresponses to Health Authorities, product labelling and investigator brochures.

You are:

• PhD/PharmD qualification or the equivalent.
• Substantial experience within the pharmaceutical industry. Along with a good understanding of theglobal pharmacovigilance and safety requirements for the registration process and onto the marketwith minimum 3 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 ofcomplex data.
• Good knowledge of relevant regulations and proven evidence of effective delivery of high qualitydocuments as well as relevant concepts in data management and systems, epidemiology andstatistics.
• Ability to act without oversight in most circumstances as well as provide key input to difficult orsensitive projects.
• The technical skills and capabilities to author and contribute to large complex documents withindocument 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 theability to a multifunctional team as well basic project management skills to allow management anddelivery of multiple complex deliverables within tight timelines.
• Have a good knowledge of GVP and relevant legislations and guidelines.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.