Global medical safety lead - homebased in uk or europe. As a global medical safety lead, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
icon is partnering with one of the industry's rapidly growing, dynamic biotech. Their truly entrepreneurial and bold approach is successfully driving to market ground-breaking treatments within the autoimmune disease portfolio. Their rapid growth strategy means you will need to be hands on, inventive in nature and highly collaborative to get things done.
you will be responsible for: leading and performing the assessment of medical safety data for assigned productsdeveloping and executing safety signaling and benefit-risk management strategiesclosely collaborating with stakeholders internally (e.g. Regulatory affairs, clinical development, medical affairs) and externally (e.g. Key opinion leaders or regulatory agencies) to align safety communications and to ensure the safe use of productsprovide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional settingperform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)contribute to the development of the overall safety governance structure and activitiesprovide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. Iss, scs, narratives) for assigned product(s)prepare and/or review safety sections of clinical/regulatory documents (including study protocols, ibs, clinical study reports, or icfs)provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accuratelead the overall preparation of periodic safety reports (e.g. Psur, dsur); provide medical safety content and ensure consistency and quality of these documentsoversee the medical assessment of individual case safety reports (icsr)confirm criteria and content for expedited reporting and unblinding (e.g. Susar or urgent safety issues)lead or actively contribute to the preparations and presentation of safety information to the data safety monitoring board (dsmb)provide medical safety contributions at internal audits and regulatory inspections you will have: strong scientific and analytic skillsability to complete multiple tasks concurrently and deliver results in a fast-paced environmentstrong ability to lead, motivate, influence, and collaborate with multidisciplinary teamsrelevant experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety (global experience is a plus)at least 1 year of experience in clinical practice or in academic medicineworking knowledge of relevant pharmacovigilance regulatory requirements and guidance documentsdemonstrated ability to perform medical assessments of safety data from multiple sourcesexperience with authoring complex documents and contributing to regulatory submissionsknowledge of adverse event reporting systemsexperience in epidemiology, biostatistics, clinical development, or medical affairs is a plus.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 entitlementsa range of health insurance offerings to suit you and your family's needscompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadglobal 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-beinglife assuranceflexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersvisit our careers website to read more about the benefits of working at icon: https://careers.iconplc.com/benefits
at 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-accommodations
interested 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.
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