Specialist, Coe Pharmacovigilance - Whippany, United States - ConnectiveRx
Description
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:
- 35 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 problemsolving 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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