Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleĪt Horizon, we know that disease does not discriminate.Embrace Diverse Perspectives: Welcome others with a respectful attitude integrate diverse perspectives into ways of working.Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments.Exhibit Intellectual Curiosity: Seek to understand what you do not know ask the right questions of the right people and sources.Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective.These three values come to life through our five Leadership Expectations that apply to all Horizon employees Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.Trusting teach other and tackling tough challenges can make a powerful difference. Familiarity with safety database ARGUS and with MedDRA.Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning is critical.A minimum of 2 years in clinical practice experience after residence training program.Direct experience in pharmacovigilance including knowledge of regulatory requirements and guidelines in US, the EU and globally.Minimum of 5 years of medical case review experience and minimum of 7 years of experience in industry, academia or patient care settings.A Physician with MD, DO or international equivalent, is required.Act as Subject Matter Expert supporting internal and external audits and inspections from regulatory agency and business partners as required.Assist in monthly quality evaluation of medical case review through ICSR review, feedback to vendor's Medical Review team, to ensure continuous process improvement.Provide oversight, training and metrics review of ICSR Service Provider where applicable to ensure ICSR process at high quality level.Maintain deep-knowledge of product labeling documentations (e.g., RSI, USPI, SmPC, etc) and provide input for labeling updates as required.Ensure PV queries are issued as appropriate for SAEs/SUSARs/AESIs and make urgent follow-up medical queries in coordination with Product Lead Safety Physicians and Medical Monitors when necessary.Identify potential safety signals at single case level and escalating Product Lead Safety Physician/PV Scientist and Medical Monitors, and upper management as necessary. ![]() Review search strategy for Analysis of Similar Events (AoSEs) and contribute to and approve company comments and assessment for SUSAR/IND Safety Reports. Analysis and assessment of SUSARs and important cases (designated medical events, AEs of special interest, etc.).Serve as safety medical expert and provides oversight on vendor's medical assessment of ICSRs for all company products throughout life cycles.Provide the medical and clinical expertise needed to perform medical review of Individual Case Safety Report (ICSR) mainly from clinical trials, as well as from literature, post marketing studies and post marketing spontaneous reports to determine the event seriousness, expectedness, company causality, ensure complete and timely review aligning with internal and external reporting timelines.The Medical Director will lead the review of Individual Case Safety Report (ICSR) and provide oversight on vendor's medical assessment of ICSRs. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. ![]() The exceptional support we provide patients and communities equally extends to our employees. Start a career that enables you to live up to your potential and help others live up to theirs. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. ![]() At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved.
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