Specialist, CoE Pharmacovigilance

Overview:

As our business continues to grow and additional programs come online, we are looking to hire additional resources to help support our Patient Contact Centers.

• Handle escalated concerns from clients, junior level Pharmacovigilance (PV) staff and/or Contact Center employees related to Pharmacovigilance.
• Provide advice and recommendations on best practices, coaching leaders and contact center staff on PV matters
• Troubleshooting problems, documenting and performing Corrective and Preventive Actions
• Review Pharmacovigilance reports to ensure accurate and complete description of information is used appropriately
• Use Quality Management and clients database to submit reports to drug manufacturers
• Perform audits of calls, faxes, and other forms of communication from patients, healthcare providers to ensure data is captured and reported.
• Independently perform or assist the Manager of Pharmacovigilance with periodic reconciliation activities.
• Report total number of Pharmacovigilance reports sent to manufacturers within a particular time period.
• Evaluate and update SOPs and Work Instructions related to Pharmacovigilance processes to ensure compliance.
• Work to maintain a constant state of 100% training compliance.
• Work with legal and contract team to review content in new or revised draft client agreements to ensure contents related to Pharmacovigilance are aligned with ConnectiveRx capabilities and service offerings.
• Monitor compliance to Pharmacovigilance programs through various means including call monitoring, review original source documents, direct observation, internal auditing, quality assurance/quality control activities.
• Document results according to ConnectiveRx Quality Management System.
• FDA regulations related to Post marketing Safety Reporting requirements.
• Able to positively identify and classify various types of reportable drug safety events.
• Basic understanding of medical and clinical terminology.

Experience:

• 3-5 years of experience in a medical, pharmacy or healthcare environment (preferably call center or claims processing)
• HUB service operations center preferred.
• Quality control / Quality Assurance experience is a plus.

Skills:

• High level of reading and verbal comprehension
• English required, Spanish or other languages considered a plus
• Highly proficient in Microsoft Office suite including Word, PowerPoint and especially Excel.
• Competency in clearly and concisely articulating medical and clinical information to manufacturer representatives.
• Must utilize problem-solving skills to resolve concerns and escalated issues.
• Ability to learn and successfully utilize Quality System software such as Trackwise Digital/Sparta.