Job – Patient Services Pharmacovigilance Quality Analyst
Location : New Have CT – (Hybrid)
Duration : 12 Months
Job Overview :
As a Pharmacovigilance Quality Analyst , you will support the Patient Services Team across all US-approved products . Your main focus will be to manage and analyze adverse event (AE) data, ensuring compliance with pharmacovigilance (PV) regulations. You'll also collaborate cross-functionally within Patient Services and the wider Commercial organization to maintain quality and safety standards.
Key Responsibilities :
- Pharmacovigilance Support :
- Assist Patient Services with PV activities for US-approved products.
- Case Processing :
- Collect, analyze, and report adverse events and safety data from various sources, ensuring compliance with global / local regulations and work instructions.
- Cross-Functional Collaboration :
- Work with multidisciplinary teams to ensure accuracy and completeness of safety data.
- Quality & Compliance :
- Perform quality reviews of adverse event reports.
- Support PV training programs.
- Respond to follow-up requests for additional information on reported AEs.
- Data Analysis & Trends :
- Identify potential safety trends and escalate appropriately.
- Administrative Support :
- Maintain accurate documentation and records.
- Assist with Patient Services scheduling.
- Support data intake and quality improvement initiatives.
- Confidentiality :
- Maintain the highest standards of patient confidentiality and data security.
Minimum Qualifications :
1+ year of experience in healthcare, rare disease, or a related field(e.g., case management, social work, insurance, patient advocacy)Strong organizational skills and ability to thrive in a fast-paced environmentExcellent verbal and written communicationDetail-oriented with strong time managementProfessional demeanor and strong interpersonal skillsIndependent problem solver with analytical thinkingAble to manage multiple tasks and work independentlyComfortable using a computer and standard office software toolsPreferred Qualifications :
1+ years of pharmaceutical or biotech industry experience1+ years of Patient Services experienceProficient in :Salesforce platformMicrosoft Outlook, Word, and ExcelDemonstrated critical thinking in aligning business strategy with patient servicesWork Environment :
Primarily office-based; requires regular computer use, phone / video communication, and collaboration with teams during standard business hours.Flexibility for 60% onsite presence in New Haven, CT.