Pharmacovigilance Associate, Alliance

Company: Horizon Therapeutics
Location: Waukegan
Posted on: May 22, 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 Pharmacovigilance Specialist will support the Pharmacovigilance Alliance Management and EU QPPV team The team is responsible for the drafting, negotiating and oversight of Pharmacovigilance Agreements with our Business Partners and Vendors. The team is also responsible for the production of the EU Pharmacovigilance System Master File (PSMF) as well as other national PSMFs. This position will report into the Head of Alliance and Regional PV Management and will play a key role in ensuring Horizon Pharma have contracts and PV provisions in place with our Business Partners and Vendors as well as ensuring we are compliant with our obligations set out in agreements. Responsibilities Supporting the EU QPPV Office and in particular the PSMF maintenance and oversight of the local QPPV network and activities. Supporting the administration of Horizon's global network of local QPPVs Preparing training materials and delivering PV training to PV vendors Tracking and oversight of Business Partners and Vendors Tracking and oversight of PV obligations in Pharmacovigilance agreements Reviewing vendor contracts for inclusion of PV provision Taking minutes during team meetings and meeting with Business Partners and vendors Drafting and negotiating amendments and terminations General administrative support to the PV alliance and EU QPPV office team Qualifications and Skills Required Science degree. Minimum of 2 years of experience in the pharmaceutical industry. Knowledge of pharmacovigilance regulations. This role requires strong initiative and capacity to work independently. You should have a good attention to detail and the ability to effectively prioritise 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. 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, Waukegan , Pharmacovigilance Associate, Alliance, Other , Waukegan, Illinois