Medical Director, Patient Safety and Pharmacovigilance
Rockville, MD, United States
At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. 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. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us.
The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives.
Position Summary:
The Medical Director will lead the review of Individual Case Safety Report (ICSR) and provide oversight on vendor's medical assessment of ICSRs.
Responsibilities:
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.
Serve as safety medical expert and provides oversight on vendor's medical assessment of ICSRs for all company products throughout life cycles.
Analysis and assessment of SUSARs and important cases (designated medical events, AEs of special interest, etc.). Review search strategy for Analysis of Similar Events (AoSEs) and contribute to and approve company comments and assessment for SUSAR/IND Safety Reports.
Identify potential safety signals at single case level and escalating Product Lead Safety Physician/PV Scientist and Medical Monitors, and upper management as necessary.
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
Maintain deep-knowledge of product labeling documentations (e.g., RSI, USPI, SmPC, etc) and provide input for labeling updates as required.
Provide oversight, training and metrics review of ICSR Service Provider where applicable to ensure ICSR process at high quality level.
Assist in monthly quality evaluation of medical case review through ICSR review, feedback to vendor's Medical Review team, to ensure continuous process improvement
Act as Subject Matter Expert supporting internal and external audits and inspections from regulatory agency and business partners as required.
Qualifications and Skills Required: A Physician with MD, DO or international equivalent, is required
Minimum of 5 years of medical case review experience and minimum of 7 years of experience in industry, academia or patient care settings.
Direct experience in pharmacovigilance including knowledge of regulatory requirements and guidelines in US, the EU and globally.
A minimum of 2 years in clinical practice experience after residence training program
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
Familiarity with safety database ARGUS and with MedDRA
Our Values Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.
These three values come to life through our five Leadership Expectations that apply to all Horizon employees Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role
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At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better.
Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.