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Job Information
ICON Clinical Research Global Medical Safety Lead - Home-Based in Remote, United States
As a Global Medical Safety Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
Perform 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 activities
Provide 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 accurate
Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
Oversee 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
Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners
Participate in cross-functional teams and initiatives
All other responsibilities as required
You Are:
MD degree or equivalent required
At least 7 years of relevant 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 medicine
Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
Demonstrated ability to perform medical assessments of safety data from multiple sources
Experience with authoring complex documents and contributing to regulatory submissions
Knowledge of adverse event reporting systems
Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus
Strong scientific and analytic skills
Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams
Excellent presentation skills with the ability to communicate complex issues clearly
Relevant computer skills, including proficiency with Microsoft Office
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/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 organization. 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 this form (https://careers.iconplc.com/reasonable-accommodations) .