Specialist, Pharmacovigilance

ConnectiveRx•Pittsburgh, PA

2d•$19 - $26•Onsite

About The Position

Under direct supervision of the department manager or supervisor, the Specialist, Pharmacovigilance is focused on meeting ConnectiveRx’s obligations for Drug Safety Monitoring and Reporting as required by the pharmaceutical manufacturers we support. The Specialist ensures that ConnectiveRx operates in a constant state of compliance with Pharmacovigilance activities.

Requirements

Associate degree or professional diploma in healthcare, pharmacy, or a medical-related field, or four years of equivalent relevant experience.
Two to four years of experience in a medical, pharmacy, or healthcare environment (preferably in a call center or claims processing).
Strong reading and verbal comprehension.
Proficiency in English required; Spanish or other languages are a plus.
Highly proficient in Microsoft Office applications including Word, PowerPoint, SharePoint, and Excel.
Ability to clearly and concisely articulate medical and clinical information to manufacturer representatives.
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.
Process Knowledge: Identifies, documents, and monitors key processes needed to achieve business results. Drafts procedures that comply with processes and implements process improvement recommendations.
Decision Quality: Makes appropriate and timely decisions using analysis, knowledge, and judgment, even with incomplete information. Evaluates and prioritizes factors to reach sound solutions.
Service Orientation: Anticipates and addresses customer needs, sometimes before they are voiced. Provides thoughtful, empathetic, prompt, and courteous service to internal and external customers.
Consultation Communication: Provides guidance to stakeholders, offering solutions based on best practices and supporting organizational objectives such as culture change, restructuring, or training.
Adhere to all company policies, procedures, and training consistent with ConnectiveRx’s Information Security and Compliance Programs, including SOC1, SOC2, PCI, and HIPAA.
Maintain strict compliance with company and client policies regarding business rules and ethics, as well as all applicable laws and regulations.

Nice To Haves

Medical call center or medical claims experience preferred.
Quality Control or Quality Assurance experience is a plus.
Spanish or other languages are a plus.

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.
Monitors and audits 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.
Performs other duties as assigned.