Pharmacovigilance Specialist

Description:

• Review written Adverse Events and/or Product Quality Complaint reports submitted to the drug manufacturer. Ensure timely and accurate transcription of data into the Quality Management System software and meet Client and manufacturer requirements and standards. Following QC checks ensure reports are submitted to manufacturer as required.
• 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.
• Assist Pharmacovigilance teammates with tasks such as periodic reconciliation, records inspection, or internal audit activities.
• Under the direct supervision of the Manager, assist with internal audit support, and preparation for 3rd party audits.
• Other duties as assigned "

Skills:

• 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
• Medical call center or medical claims experience preferred.
• 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, SharePoint and Excel.
• Competency in clearly and concisely articulating medical and clinical information to manufacturer representatives
• 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
• Ability to learn and successfully utilize Quality System software
• 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. "

Education:

• Associate s degree or professional diploma in a healthcare, pharmacy or medical related field, or equivalent experience. "