Sr Manager, Pharmacovigilance Scientist

Company: Horizon Therapeutics
Location: Glenview
Posted on: May 8, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary: The Senior Manager, Pharmacovigilance Scientist is responsible for managing and tracking of safety science deliverables to internal and external customers.

Responsibilities:

• Manages and tracks the production of periodic safety reports (PADER, PBRER, DSUR) and the department's contribution to annual reports (NDA Annual Report and IND Annual Report)
• Manages and tracks the safety surveillance strategies for the company's development and marketed products
• Manages the identification, prioritization, and assessment of safety signals
• Manages and tracks the production of risk management plans for the company's marketed products
• Manages and tracks ad hoc safety analyses in response to health authority, DSMB, and Ethics Committee/IRB queries
• Manages, tracks, and makes updates to safety management plans for company-sponsored studies
• Assists with the development of safety sections of study protocols, clinical study reports, investigator brochures, and other related clinical documents
• Manages and tracks other safety science deliverables to internal and external customers
• Participates in cross-functional teams as a PV representative
  
  Qualifications and Skills Required:
  
  • Bachelor's degree or equivalent (health professional degree preferred)
  • 5+ years of pharmaceutical or biotechnology experience of which 3+ years in a pharmacovigilance setting
  • Previous experience with safety databases (Argus, ARISg, or equivalent)
  • Knowledge and understanding of pharmacovigilance regulations for both marketed and investigational products
  • Proficient in Microsoft Office
  • Professional, proactive demeanor
  • Strong interpersonal skills
  • Excellent written and verbal communication skills
    Horizon Core Values & Competencies:
    
    Growth
    
    • Manages Ambiguity
    • Strategic Mindset
    • Demonstrates Self-awareness
    • Cultivates Innovation
    • Develops Talent
      
      Accountability
      
      • Drives Results
      • Ensures Accountability
      • Decision Quality
        
        Transparency
        
        • Courage
        • Collaboration
        • Instills Trust
          
          Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.
          
          Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Glenview , Sr Manager, Pharmacovigilance Scientist, Executive , Glenview, Illinois