Medical Director, Pharmacovigilance

Working at Horizon Pharma is more than a job - it's personal. We define success by a different set of numbers: the number of lives touched, the number of lives changed, the number of lives saved. 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 patients live up to theirs.

Responsibilities:

• Leading the development of translational, product-specific safety surveillance plans
• Providing oversight of individual case safety reports including review and assessment of seriousness, expectedness, medical coding, and creation of follow-up for assigned products
• Leading safety signal detection and management for assigned development and marketed products
• Overseeing safety-related updates to RSI, CSI
• Leading clinical safety activities for development products including safety sections of the protocol and clinical study reports
• Contributing to safety sections of submission documents (NDA/BLA/MAA)
• Representing Patient Safety and Pharmacovigilance on cross functional teams
• Analyzing/interpreting safety data and authoring safety-relevant sections of of product-specific regulatory deliverables, including MA submissions, in collaboration with cross-functional teams

Qualifications and Skills Required:

• MD or DO. Board Certified/Board Eligible or equivalent.
• For medical director-level candidates, 3- 5 years' experience in the pharmaceutical industry and at least 3 years focused on pharmacovigilance
• Expertise in global pharmacovigilance and clinical safety regulations and guidelines
• Ability to objectively interpret, analyze and communicate medical and scientific data
• Experience with MedDRA coding and drug safety databases
• Strong communication skills both written and verbal
• Ability to develop and maintain collaborative relationships
• Proficient in Microsoft Office

• High degree of professionalism
• Self-starter attitude
• Strong interpersonal skills
• Excellent written and verbal communication skills

Essential Core Competencies:

• Action Oriented
• Problem Solving
• Organization
• Functional/Technical Skills
• Priority Setting
• Drive for Results
• Strategic Agility
• Intellectual Horsepower
• Dealing with Ambiguity

Core Behaviors:

• Integrity and Trust
• Composure
• Standing Alone

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 Pharma 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.