Job Description

This is what you will do:
The Pharmacovigilance Quality Specialist will support the 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 the Commercial organization.
You will be responsible for:
• 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

You will need to have:
• 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.

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

Job Tags

Contract work, Work at office, Local area,

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