Product Inquiry and Complaint Specialist All can be filled in either the Duluth, GA or St Joseph, MO areas. Hours will be ~9-6 EST / 8-5 CST. 40 hours/week. 12 month assignments. Purpose: Addresses and responds to all product inquiries, complaints, and suspected adverse events in a timely and appropriate manner and in compliance with US regulations (FDA, USDA, EPA), relevant GMPs, BIVI policies and procedures for the capture, maintenance and reporting of adverse events and product quality complaints. Receive all product inquiries, complaints, and suspected adverse events that may arise by usage of or experience with BIVI products. Communication may be received from (but are not limited to) veterinarians, veterinary technicians and other veterinary support staff, consumers (pet owners), BIVI sales personnel, distributor sales representatives, or other BIVI personnel. The major form of communication is via telephone but may include email and hand delivered mail. Provide information and support as requested in the following areas: proper product use, extra-label use, literature requests, adverse events, and unexpected response to treatment, perceived lack of efficacy, and product or packaging defects. Maintain a high level of technical and clinical expertise related to BIVI products. Constantly upgrade technical expertise by reading journals and attending scientific seminars. Document all communications within the BIVI Validated Database (PVWorks) in accordance with BIVI SOPs and all compliance/GMP requirements, and assess and implement appropriate responses and procedures. Ensure timely and accurate communication and adherence to all BIVI SOPs, including escalating calls to Technical Services Veterinarians as needed. Support external and internal sales representatives as needed by providing technical support, answering client inquiries and attending and working at veterinary conferences. Research pertinent topics and prepare reports as requested by the Manager. Participate in call analysis and report trends or issues involving product usage. Perform additional duties as assigned. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation within the animal health community and internally. Must be able to understand and apply relevant GMPs and have an understanding of pharmacovigilance and complaint handling Compliance requirements. This position requires someone with a strong customer service background and a commitment to excellence. This position must understand the balance of providing customer service in a regulatory compliance environment to ensure strict adherence to all principles of good product stewardship in an effort to maximize product sales. Must understand the balance of providing excellent customer service in a regulatory compliance environment Must possess a strong understanding of basic veterinary practice issues and procedures. Attention to detail, quality focused and strong technical and problem solving skills. Excellent computer skills required (Microsoft Office Suite). Excellent oral and written communication skills and an ability to operate effectively in a team environment. Must have excellent organization and time management skills. Ability to manage conflict and to balance business needs with user friendliness. Ability to work independently, under pressure, demonstrating initiative and flexibility. Animal Health or related industry and/or regulatory experience a plus Regulatory Functional Competencies Knowledge of Pharmaceutical Life Cycle Process - Level 1, Developing Developing Knowledge of Reg Requirement & Compliance – Level 1, Developing Leveraging Strategic Relationships - Level 1, Developing Managing Conflict –Level 1, Developing Negotiation Skills –Level 1, Developing Market knowledge - Level 1, Developing R&D Core Competencies Business and Technical Knowledge - Level 1, Developing Customer Orientation - Level 1, Developing Communication - Level 1, Developing Delivering Results - Level 1, Developing External Focus - Level 1, Developing Fast and Focused Execution - Level 1, Developing Innovation and Change - Level 1, Developing Lives Lead & Learn - Level 1, Developing Planning and Organization - Level 1, Developing Quality Orientation/Business Process Excellence - Level 1, Developing Teamwork and Collaboration - Level 1, Developing Winning Vision - Level 1, Developing Problem Solving / Resolution - Level 1, Developing Associate Degree or higher (Life Sciences/Veterinary Technician)ANDa minimum of 3 years experience working in a veterinary clinic (veterinary assistant and/or technician)
