Patient Safety Specialist I

Job Title: Patient Safety Specialist I
Location: Plainsboro – ONSITE (the worker can work from home a few days a week after discussion with the reporting manager, as needed)
Salary Range: $30-$32

Introduction

This role is responsible for the receipt, processing, triage, and quality assessment of all inbound safety information, including adverse events and technical complaints, for Client Inc.'s US marketed products (drugs and devices) and investigational products. The role also ensures compliance with all internal and external (e.g., FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety records.

Required Skills & Qualifications

• A bachelor’s degree is required (preferably in a medical or science-related discipline); relevant experience may be substituted for the degree when appropriate (e.g., a Registered Nurse with clinical experience).
• A minimum of 2 years of progressively responsible and relevant pharmacovigilance experience, including MedDRA coding and adverse event identification, is required.
• Exceptional knowledge of medical and pharmacovigilance terminology is required.
• Prior work experience at the client or in the client's industry.

Preferred Skills & Qualifications

• A minimum of 2 years of Customer Service experience preferred.
• Knowledge of NNI supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders).
• Experience with audits/inspections preferred.
• Experience with a Call Center and Drug Safety database preferred.
• Bi-lingual (Spanish-English) a plus.

Day-to-Day Responsibilities

• Process adverse events and associated technical complaints and analysis results related to marketed products into the local intake, complaint, and global safety databases.
• Perform triage, case classification, and case assignment.
• Provide professional, accurate, and timely responses to product information questions and other inquiries using current approved product labeling and call scripts.
• Assist with training of new hires and mentor new hires.
• Support the identification of trends and implementation of corrective actions for issues identified during case review.

Company Benefits & Culture

• Build customer loyalty by providing high-quality customer service.
• Opportunity to work in a fast-paced environment with multiple priorities and demands.
• Engage with various levels of the organization and form strong working relationships with stakeholders.

For immediate consideration, please click APPLY to begin the screening process with Alex.