Specialist, Pharmacovigilance

Responsibilities

• Reviews written Adverse Event and Product Quality Complaint reports submitted to the drug manufacturer.
• Ensures timely and accurate transcription of data into the ConnectiveRx Quality Management System and that reports meet company and manufacturer requirements and standards.
• Conducts quality checks and ensures reports are submitted to the manufacturer as required.
• Maintains monitoring and auditing of potential sources of safety information under the guidance of the Manager, Pharmacovigilance. Sources may include recorded calls, claims, faxes, text messages, chat logs, and other records.
• Ensures all safety data identified is captured, recorded, and reported in compliance with company SOPs.
• Assists Pharmacovigilance teammates with tasks such as periodic reconciliation, records inspection, and internal audit activities.
• Supports internal audits and preparation for third-party audits under the supervision of the Manager.

Qualifications

• Education/Degree Requirements: Associate degree or professional diploma in healthcare, pharmacy, or a medical-related field, or four years of equivalent relevant experience.
• Experience: Two to four years of experience in a medical, pharmacy, or healthcare environment (preferably in a call center or claims processing).
• Medical call center or medical claims experience preferred.
• Quality Control or Quality Assurance experience is a plus.
• Knowledge: Strong reading and verbal comprehension. Proficiency in English required; Spanish or other languages are a plus.
• Skills: Strong problem-solving skills with the ability to resolve issues independently or escalate when needed. Ability to organize and prioritize work across multiple systems to meet reporting deadlines. Ability to learn and successfully utilize Quality System software. Accurate transcription of text or audio information. Effective communication of ideas and concepts. Responsive, attentive, patient, respectful, and professional with colleagues, leadership, and manufacturer contacts. Strong analytical skills, results orientation, and attention to detail.