Manager, PSPV Technical Systems

Company: Horizon Therapeutics
Location: Bethesda
Posted on: May 21, 2023

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
The Manager, PSPV Technical Systems is responsible for assisting with the evaluation, implementation and support of the department's computerized systems used to in the collection, processing, analyzing and reporting of safety data received by Horizon, its employees, partners and vendors. The Manager contributes to continuous improvement and standardization of PSPV processes and methods.
Responsibilities

• Assists in the evaluation of the technical and analytical needs of the department and maximizes the capabilities of the safety database and other safety related pharmacovigilance systems
• Assists in the project-specific configuration of the safety database to meet the regulatory needs of the department
• Maintains user requirements for all computerized systems owned by the department
• Assists in the implementation of project specific safety database configurations to meet the regulatory and business needs of the department
• Participates in system validation activities for the safety database and other safety-related systems
• Works with external consultants on systems projects
• Facilitates the communication between the internal and external business users, IT, Quality, and the database vendor
• Assists in the development of business cases and system roadmaps
• Assists with data management of safety-related PV systems
• Other duties as assigned
  Qualifications and Skills Required
  
  • Bachelor's degree in health sciences, computer science, information systems or related field or relevant combination of education and experience required
  • 3+ years of biotech/pharmaceutical experience in drug safety/Pharmacovigilance
  • Experience working with PV safety databases/other database systems and safety data visualization systems preferred (Argus, ARISg, or equivalent)
  • Previous experience in assistance with User Acceptance Training, database workflow structure and computer system validation preferred
  • Proficient in Microsoft Office
  • Professional, proactive demeanor
  • Strong interpersonal skills
  • Excellent written and verbal communication skills
  • Requires approximately 5-10% travel, including some overnight and weekend commitments
    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
        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.

Keywords: Horizon Therapeutics, Bethesda , Manager, PSPV Technical Systems, IT / Software / Systems , Bethesda, Maryland