Pharmacovigilance Quality Analyst

Description

• 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

Qualifications

• 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.