Global Medical Safety Lead - Home-Based

As a Global Medical Safety Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• 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
• 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

Why 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.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.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, colour, 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.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.

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**