Patient Safety Associate II (Remote-Hybrid)

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

Occasional onsite work is required approximately three days per month.

Purpose and Scope

Under limited supervision, coordinates investigations into product complaints received by Tolmar Inc. Authors, compiles Customer Complaint investigations and generates Product Quality Review Reports. Monitors and trends key areas and indicators from customer complaints for implementation of corrective and preventative measures.

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 provider's reconciliation tasks for Clinical and Post-marketing (Medical Information, Product Complaints and third-party vendor ) cases.
• Clearly and succinctly communicates information to customers verbally and in writing.
• Demonstrate a high level of customer service to both internal and external customers.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Evaluate returned samples and report initial evaluation findings to key personnel.
• 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.
• Coordinate with other departments to complete investigations and reports.
• Conduct statistical analyses to identify trends, drive quality improvements and support Post-Market Surveillance activities by gathering the relevant data and generating periodic complaint trending reports.
• Prepare complaint reports for distribution to senior management.
• Provide sub reports for Annual Product Quality Reviews (APRs).
• Process change controls and update procedures as needed.
• Prepare Customer Complaint metrics, including compilation of Quality Management Review metrics.
• Participate in audits and inspections as needed.
• Provide guidance and training to other employees on the team.
• Identify opportunities for enhancing customer satisfaction and refining complaint-handling processes.
• 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 communicates and/or implements recommendations/changes.
• Effectively prioritize and manage own time to complete assigned tasks.
• Perform additional related duties as assigned.

Core Values

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

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Knowledge, Skills & Abilities

• Strong understanding of Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA), and other regulatory compliance regulations and standards.
• Leadership, project management and training methods and techniques.
• Strong attention to detail.
• Excellent troubleshooting and problem solving skills.
• Skill in writing procedures and complaint responses including higher level investigation result or position papers as required.
• Proficiency in business, scientific and personal computer hardware and software applications.
• Independent, organized, and able to schedule work without supervision to meet schedule deadlines.
• Ability to coordinate activities to assure customer needs are met.
• Proficiency in quality management software and statistical analysis tools.
• Hands-on, proactive mindset with a collaborative approach.
• Ability to work in a fast-paced, international environment.
• Superior attention to detail, quality, accuracy and timelines.
• Strong time management and prioritization skills; ability to multi-task.
• Strong adaptability to switching tasks to meet business needs.
• Strong customer service skills.
• Ability to work independently with minimal supervision as well the ability to work collaboratively and effectively within a team.
• Fast learner of technical and process skills/knowledge.
• Effective verbal and written skills.
• Medical terminology knowledge preferred.
• Ability to complete assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
• Ability to exercise judgment within specifically-defined practices and policies and select methods and techniques for obtaining solutions.

Education & Experience

• Bachelor's Degree in Science, Engineering or related field from an accredited college or university required; or an equivalent combination of education and/or experience.
• Three (3) or more years of experience in the pharmaceutical or medical device industry.
• Experience in complaints handling, root cause analysis and problem-solving methodologies required.
• Demonstrated experience with Microsoft Office Suite applications and Veeva Vault or related system preferred.

Working Environment

• Remote position, home office environment. Onsite work is required approximately three days per month.
• Complaint sample evaluations: limited exposure to fumes or odors. May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (i.e. safety glasses, gloves etc.).

Compensation and Benefits

• Pay rate: $34.00 - $36.00 (depending on experience)
• Benefits summary: https://www.tolmar.com/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.