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.

Responsibilities:
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 client’s 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.

Qualifications:
 

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.

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