ICON Strategic Solutions Global Medical Safety Lead in Boston, Massachusetts
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.
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
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.
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.
ICON Strategic Solutions
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