Patient Safety Associate I (Remote-Hybrid)

Description

Core Hours : Monday - Friday, 8am-5pm

Purpose and Scope

Under general supervision, monitors compliance with the current Good Manufacturing Practices and Company policies, procedures and specifications; performs investigations into product complaints received by Tolmar Inc.

Essential Duties & Responsibilities

• Carry out responsibilities in accordance with the organization's policies, procedures, and state, Federal and local laws.
• Maintain the Technical Complaint System and database and act as main contact for receipt of customer complaints for Tolmar Inc.
• Handle product complaints efficiently in accordance with internal procedures. This includes registering complaints, receiving complaint samples (if necessary), investigating root causes with cross-functional teams, gathering relevant data, and recommending corrective actions.
• Complete accurate and timely registration of product quality report from initial receipt to data entry within required timeframes.
• Perform Quality Review of external providers' reconciliation tasks for Clinical and Post-marketing (Medical Information, Product Complaints and third-party vendor ) cases.
• Clearly and succinctly communicate information to customers verbally and in writing.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Interact with contracted Service Provider for all issues related to complaint handling and pharmacovigilance.
• Initiate complaint investigations and coordinate all aspects of investigation through closure.
• Initiate and author deviation investigations (as applicable) and coordinate all aspects of investigation through closure.
• Liaise with Customer Experience team to gather information and provide final response to complainants.
• Analyze complaint trends using information maintained in the Customer Complaint database and initiate investigations where trends indicate.
• Provide sub reports for Annual Product Quality Reviews (APQRs).
• Process change controls and update procedures as needed.
• Identify opportunities for enhancing customer satisfaction and refining complaint-handling processes.
• Participate in audits and inspections as needed.
• Demonstrate a high level of customer service to both internal and external customers.
• Utilize judgment skills to identify issues that impact the workflow.
• Use rigorous logic and methods to solve difficult problems with effective solutions.
• Identify gaps and areas that need improvement and communicate and / or implement recommendations / changes.
• Perform tasks outside one's own area of responsibility to help with departmental needs.
• Effectively prioritize and manage own time to complete assigned tasks.
• Perform additional related duties as assigned.

Core Values

The Patient Safety Associate I is expected to operate within the framework of Tolmar's Core Values :

Knowledge, Skills & Abilities

Education & Experience

Working Environment

Compensation and Benefits

Benefits summary : careers / employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.