Pharmacovigilance Quality Analyst, 12-Month Contract

Job Description

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The Pharmacovigilance Quality Specialist will support the Alexion Patient Services Team for all US approved products. This role will be responsible for collecting, analyzing, and interpreting data related to adverse events. This role will also provide critical assistance within Patient Services and across Alexion's Commercial organization.

Key Responsibilities:

• Supporting Patient Services with pharmacovigilance activities
• Case Processing: Collecting and reporting adverse events (AEs) and other safety information reported from various sources in accordance with applicable work instructions and global/local regulatory requirements
• Work with multidisciplinary teams to ensure accurate and complete safety data and adherence to regulations
• Participate in pharmacovigilance training and support the quality team to ensure compliance with requirements
• Completing quality review of work as part of finalizing adverse event submissions
• Responding to additional information requests from Global Patient Services regarding reported adverse events
• Identify potential trends through data analysis
• Document management
• Support Workforce Manager with Patient Services scheduling
• Support Data Intake and Quality initiatives
• Maintain confidentiality regarding patient specific information

Essential Education, Experience & Skills:

• Qualified candidates should have 1+ years of experience in the healthcare/rare disease industry OR recognized equivalent of education and experience (e.g., case management, social service support, insurance reimbursement, patient advocacy, etc.)
• Strong organizational skills and ability to adapt to change and react constructively in a high-energy and fast paced environment
• Passion for patient-centric strategies
• Strong verbal and written communication skills, attention to detail and time management
• Strong interpersonal skills and professionalism
• Independent problem solver, good decision maker, and robust analytical skills
• Ability to coordinate multiple assignments simultaneously and work independently
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desired Experience & Skills:

• 1+ years of pharmaceutical/biotech experience
• 1+ years of Patient Services experience
• Proficient Windows based experience includes fundamentals of data entry/typing
  • Experience working on a Salesforce platform
  • Working knowledge of Outlook, Word, and Excel
• Experience using critical thinking to align corporate strategies and current challenges to develop recommendations

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. #LI-Hybrid

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.