Sr. Specialist, CoE Pharmacovigilance

Being on medication is tough enough. We want to make getting it the easy part. Getting prescriptions to patients has become increasingly complex. When things get messy along the prescription journey, pharmaceutical manufacturers rely on us to untangle the process and create a clear path—allowing patients to build trusting relationships with their medication brands.

We’re not only committed to taking the pain out of the prescription process, but we’re also devoted to bringing the brightest minds together under one roof. We bring together diverse voices—engineers, pharmacists, customer service veterans, developers, program strategists and more—all with one vision. Each perspective and experience makes ConnectiveRx better than the sum of its parts.

Under direct supervision of the department manager/supervisor, the Sr. Specialist, Pharmacovigilance is focused on meeting ConnectiveRx’s obligations for Drug Safety Monitoring and Reporting as required by the pharmaceutical manufacturers we support. The Sr. Specialist, Pharmacovigilance works to ensure that ConnectiveRx is operating in a constant state of compliance related to Pharmacovigilance activities. 

• Performs periodic reconciliation activities independently. Reports total number of Pharmacovigilance reports sent to manufacturers within a particular time period. Uses Quality Management and client’s database to submit reports to drug manufacturers.
• Creates, evaluates, and updates SOPs and Work Instructions related to Pharmacovigilance processes to ensure compliance.
• Maintains client training rosters and matrices to ensure a constant state of 100% training compliance. Provides classroom-based training on Pharmacovigilance matters for personnel as needed. 
• Handles escalated concerns from clients, junior level Pharmacovigilance (PV) staff and/or Contact Center employees related to Pharmacovigilance. Provides advice and recommendations on best practices, coaching leaders and contact center staff on PV matters. 
• Troubleshoots problems, documents and performs Corrective and Preventive Actions. 
• Monitors compliance to Pharmacovigilance programs through various means including call monitoring, reviews original source documents, directs observation, internal auditing, quality assurance/quality control activities. Documents results of such monitoring according to ConnectiveRx Quality Management System. 
• Assists the Quality Director and Manager, PV working 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.
• Other duties as assigned 
  • Assists Enterprise Quality leadership with RFP and audit support, and preparation for 3rd party audits. 

• Bachelor’s or master’s degree in science or healthcare field, or equivalent relevant 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.
• 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.  
• 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.
• Demonstrated ability to use time efficiently, transcribe text or audio information accurately, to clearly communicate ideas and concepts.  
• Must be responsive, attentive, patient, respectful and professional, and exemplify a positive attitude, especially in dealings with Contact Center staff, Operations leadership, and manufacturer contacts.  
• Problem solving, results orientated, analytical and high level of attention to detail.
• 10-15% - Fairfield, NJ and occasionally Pittsburgh, PA Offices, or client/subcontractor sites, as needed.
• Adhere to all Company Policies, Procedures, and other training consistent with ConnectiveRx's Information Security and Compliance Programs, including but not limited to the following compliances and regulations: SOC1, SOC2, PCI, HIPAA 
• Maintain strict compliance with company and client policies regarding business rules and ethics, as well as applicable local, state and national federal laws