Duties:
M-F, 40 hrs/week (9-6 EST)
Duluth, GA or St Joseph, MO (2 days per week on site, 3 days during initial onboarding week)
12 month assignments (with the option to renew at the end of 12 months).
Our roles are not considered fully remote, so are officially considered hybrid. Additionally, if team members do not have sufficient internet to work (or if they have an outage in their area), they would be expected to come on site to work since our offices are open.
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.
Constantly upgrade technical expertise by reading journals and attending scientific
seminars.
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.
Skills:
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 •
Last updated on Nov 10, 2023