Patient Services Pharmacovigilance Quality Analyst

Job Description

Job Summary:

• The Pharmacovigilance Quality Specialist will support the Client 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 Client’s Commercial organization.

Duties and 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.

Experience:

• 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.

Knowledge, Skills and Abilities:

• 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.