Director, Pharmacoepidemiology and Observational Research

Company: Horizon Therapeutics
Location: Schaumburg
Posted on: March 19, 2023

Job Description:

Job Description:

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:This position will oversee and assist with pharmacoepidemiology and post-authorization risk management activities for assigned products.Responsibilities:Leads the Epidemiology team and provides management oversight and direction to EpidemiologistsContributes to the design and implementation of safety-related post-marketing studies (PASS, observational studies, PMRs) including feasibility assessments, development of study designs and protocols, and communicates results to internal and external stakeholdersConducts research on natural history of disease to support safety surveillance and assessmentLeads and conducts observational studies, including but not limited to real world data analysis and real-world evidence generation with collaboration of cross-functional stakeholdersContributes to benefit: risk analysis and discussions at safety governance meetingsContributes and authors responses to safety inquiries received from global regulatory agenciesParticipates in or may lead cross-functional teams to ensure timely deliverables and submission to health authorities as requiredSupports the development and implementation of of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS)Qualifications and Skills Required:Advanced degree in epidemiology, pharmacoepidemiology, and/or related fields, PhD/DrPH preferred7+ years of pharmaceutical or biotechnology experience of which 5+ years in a pharmacovigilance, pharmacoepidemiology, or safety risk management settingExperience with biostatisticsKnowledge of regulations governing pharmacovigilance for human medicinesExperience with PV databases and statistical data analyses of clinical dataMust be able to work effectively as a team member in a highly interactive and collaborative environmentStrong analytical and writing skillsExperiences in risk management preferredProficient in Microsoft Office.Professional, proactive demeanor.Strong interpersonal skills.Excellent written and verbal communication skills.Our ValuesTransparency: 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 employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of workingDevelop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleAt 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.

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