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Medical Director, Pharmacovigilance job in Rockville at Horizon Therapeutics

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Medical Director, Pharmacovigilance at Horizon Therapeutics

Medical Director, Pharmacovigilance

Horizon Therapeutics Rockville, MD Full-Time
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 Medical Director, Patient Safety and Pharmacovigilance, will lead the development and execution of safety strategies for development and marketed products including surveillance planning, signal detection, evaluation and risk management. This position will collaborate cross-functionally and is accountable for developing and maintaining in-depth knowledge of the safety and overall benefit-risk profiles of company products.

Responsibilities:

  • Lead the development and execution of translational, product-specific safety surveillance plans
  • Review, interpret and summarize safety data for specific deliverables (periodic reports, risk management plans, protocols, SAP, IB, IC, CSR, CTD)
  • Provide oversight, review and assessment of individual case safety reports and other patient-level safety data taking into consideration translational safety information
  • Present data and analyses to multiple internal/external stakeholder groups
  • Collaborate cross functionally on development teams, safety management teams
  • Able to chair or co- chair a Safety Review Team
  • Able to present or co-present to the safety review board
  • Maintain in depth knowledge of evolving global clinical development and pharmacovigilance regulations, methodologies and technologies
  • Develop and mentor staff


Qualifications and Skills Required:
  • MD or DO; Board Certified/Board Eligible or equivalent
  • 3- 5+ years' experience in the pharmaceutical industry and at least 3+ years focused on clinical safety/pharmacovigilance
  • Expertise in global pharmacovigilance and clinical safety regulations and guidelines
  • Ability to objectively interpret, analyze and communicate medical and scientific data
  • Experience with drug safety databases (queries, reporting, visualization tools) and MedDRA coding
  • Strong written and verbal communication skills
  • Ability to cultivate and maintain collaborative relationships
  • Proficient in Microsoft Office
  • High degree of professionalism
  • Self-starter attitude
  • 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.

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  • Communication
  • Customer Service
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Job ID: AR05-16369_R0003990

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