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Associate Director, Pharmacovigilance Risk Management

Company: Horizon Therapeutics plc
Location: Deerfield
Posted on: April 10, 2021

Job Description:

Associate Director, Pharmacovigilance Risk Management 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: This role is focused on supporting and leading global pre/post-authorization risk management activities across the enterprise. This role requires good judgment and strong initiative. You need to have the ability to effectively prioritize and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent w r i tten a nd v erbal c o m m uni c ation s ki l ls. Responsibilities:

  • Maintain current knowledge of RMP/REMS regulatory trends/guidelines and best practices
  • Provides subject matter expertise in risk management/risk evaluation and mitigation strategies (REMS) in the assessment of product benefit-risk across therapeutic areas within the enterprise
  • Leads and advises on the strategy and preparation of global RMPs and REMS across therapeutic areas within the enterprise
  • Contributes and authors responses to safety inquiries received from global regulatory agencies relating to product RMPs, REMS and benefit-risk assessments
  • Leads the development, implementation, and assessment of the effectiveness of risk minimization measures endorsed by the Safety Review Board
  • Oversee product team compliance with PSPV risk management and benefit-risk processes
  • Participates in risk communication planning Qualifications and Skills Required:
    • Advanced degree in life sciences
    • 5 years of pharmaceutical or biotechnology experience of which 3+ years in a pharmacovigilance and safety risk management setting
    • Experience with developing risk management plans or risk evaluation and mitigation strategy, risk minimization tools, authoring RMP and REMS
    • Experience with assessing the effectiveness of additional risk minimization measures or activities and the evaluation of REMS methods
    • Must be able to work effectively as a team member in a highly interactive and collaborative environment
    • Excellent interpersonal, communication and negotiating skills
    • Proficient in Microsoft Office.
    • Strong interpersonal skills.
    • Excellent written and verbal communication skills. Horizon Core Values & Competencies:
      -- Growth
      • Manages Ambiguity
      • Strategic Mindset
      • Demonstrates Self-awareness
      • Develops Talent Accountability
        • Drives Results
        • Ensures Accountability
        • Decision Quality Transparency
          • Courage 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. Posted 5 Days Ago Full time R0002379 About Us Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter , LinkedIn , Instagram and Facebook .

Keywords: Horizon Therapeutics plc, Arlington Heights , Associate Director, Pharmacovigilance Risk Management, Executive , Deerfield, Illinois

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