What are the responsibilities and job description for the Specialist, Pharmacovigilance position at ConnectiveRx?
Pharmacovigilance is essential to these functional areas and due to promotion, we are looking to hire a Specialist who reports to the Manager, Pharmacovigilance here in our Whippany, NJ office.
Essential Functions
Under the direct guidance and supervision of the Manager, Pharmacovigilance: Monitor and audit all potential sources of safety information including (but not limited to) recorded calls, claims, faxes, text messages, chat logs and other records for the presence of Adverse Events and/or Product Quality Complaints. Ensure all safety data found is captured, recorded and reported per company SOPs.
Review written Adverse Events and/or Product Quality Complaint reports submitted to the drug manufacturer to ensure they are detailed, accurate and complete and meet ConnectiveRx and manufacturer requirements and standards.
Ensure timely and accurate transcription of Adverse Event and/or Product Quality Complaints data into the ConnectiveRx Quality Management System software.
Assist the Manager of Pharmacovigilance and/or Senior Specialists with periodic reconciliation, records inspection, or internal audit activities.
Report total number of Pharmacovigilance reports sent to manufacturers within a particular time period utilizing the ConnectiveRx Quality Management System and indicate whether those reports were delivered on time.
Assist with internal audit support, and preparation for 3rd party audits.
English Required, Spanish Or Other Languages Considered a Plus
Highly proficient in Microsoft Office suite including Word, PowerPoint and especially Excel.
High level of reading and verbal comprehension
Must utilize problem-solving skills to resolve concerns independently, or escalate problems to Senior Specialists and the Manager when assistance or clarification is needed
Must be able to organize and appropriately prioritize work within multiple systems concurrently to ensure client deadlines for reporting are met
1-2 years of experience in a medical, pharmacy or healthcare environment (preferably call center or claims processing)
Quality control / Quality Assurance experience is a plus.
Education
Associates degree or professional diploma in a healthcare, pharmacy or medical related field, or equivalent experience
Essential Functions
Under the direct guidance and supervision of the Manager, Pharmacovigilance: Monitor and audit all potential sources of safety information including (but not limited to) recorded calls, claims, faxes, text messages, chat logs and other records for the presence of Adverse Events and/or Product Quality Complaints. Ensure all safety data found is captured, recorded and reported per company SOPs.
Review written Adverse Events and/or Product Quality Complaint reports submitted to the drug manufacturer to ensure they are detailed, accurate and complete and meet ConnectiveRx and manufacturer requirements and standards.
Ensure timely and accurate transcription of Adverse Event and/or Product Quality Complaints data into the ConnectiveRx Quality Management System software.
Assist the Manager of Pharmacovigilance and/or Senior Specialists with periodic reconciliation, records inspection, or internal audit activities.
Report total number of Pharmacovigilance reports sent to manufacturers within a particular time period utilizing the ConnectiveRx Quality Management System and indicate whether those reports were delivered on time.
Assist with internal audit support, and preparation for 3rd party audits.
English Required, Spanish Or Other Languages Considered a Plus
Highly proficient in Microsoft Office suite including Word, PowerPoint and especially Excel.
High level of reading and verbal comprehension
Must utilize problem-solving skills to resolve concerns independently, or escalate problems to Senior Specialists and the Manager when assistance or clarification is needed
Must be able to organize and appropriately prioritize work within multiple systems concurrently to ensure client deadlines for reporting are met
1-2 years of experience in a medical, pharmacy or healthcare environment (preferably call center or claims processing)
Quality control / Quality Assurance experience is a plus.
Education
Associates degree or professional diploma in a healthcare, pharmacy or medical related field, or equivalent experience
