Global Medical Safety Lead - Homebased in UK or Europe.

Overview

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.

 

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Responsibilities

You will be responsible for:

• Leading and performing the assessment of medical safety data for assigned products
• Developing and executing safety signaling and benefit-risk management strategies
• Closely 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 products
• 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

Qualifications

You will have:

• 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
• 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.

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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 vou