Job Description

To lead pharmacovigilance operations and support Virbac initiatives regarding regulatory compliance, vendor management, and medical review of materials, while providing leadership for special projects and departmental onboarding.

Area of responsibility 1: Oversee Pharmacovigilance operations

Main responsibilities:

• Lead onboarding of new Pharmacovigilance employees.

• Cultivate the development of individual skills, people development, and teamwork within the department and across departments.

• Ensure PV team members participate in, successfully complete, and apply directions and principles from all training for each applicable SOP and/or Work Instruction for their job function.

• Ensure high levels of collaboration within Virbac Corp.

• Ensure that information about all adverse events which are reported to any personnel of VIRBAC, is collected and securely collated in order to be accessible

• Ensure that new information relevant to the benefit-risk balance of a product is reported to the Regulatory Authorities in a timely manner

• Enable VIRBAC to maintain responsibility for its products on the markets and to ensure that appropriate action may be taken, when necessary

• Ensure Virbac Corp. maintains communications that establish and maintain trust with regulatory authorities.

• Comply with all local and global legal requirements for pharmacovigilance. ● Oversee the budget (P&L) associated with Pharmacovigilance operations. Communicate budget needs with management as requested.

Expected results: Virbac Corp. maintains compliance with all regulatory authority pharmacovigilance regulations. Ensures the Pharmacovigilance Consulting and Reporting department remains in compliance with all company SOPs and contributions toward overall compliance with Agency Regulations. Successfully manages team operations and fosters people development.

Area of responsibility 2: Provide consultations and pharmacovigilance support for Virbac’s marketed products and R&D or Business Development projects

Main responsibilities:

• Consult with members of the Pharmacovigilance Reporting (PR), R&D, Business Development, and Quality Assurance teams regarding medical and/or non-medical aspects of PV cases.

• Provide Assessment of case events as requested or required by Departmental and/or Company SOPs and/or Work Instructions and/or in response to special requests from either within or outside the Department.

• Provide Health Hazard Assessments for a potential 3-Day Field Alert, Recall or Withdrawal.

• Perform or delegate tasks to PV team as required, related R&D or business development projects (ex: review of adverse events for product labeling, contract negotiations)

Expected results: Helps department remain in compliance with all company SOPs and contributes toward overall compliance with regulations governing pharmacovigilance for the Company. Helps support Virbac’s business decisions.

Area of responsibility 3: Vendor and other third party management

Main responsibilities:

• Maintain agreements with all vendors providing services to the department.

• Ensure compliance of vendors with required operating procedures that affect compliance of Virbac Corp. pharmacovigilance relative to regulatory authorities. Interact with manufacturers and re-distributors of Virbac Corp. products as needed, including through formal agreements and ad hoc communications, to ensure maintenance of required pharmacovigilance compliance with regulatory authorities.

Expected results: The department maintains strong business relationships to support pharmacovigilance requirements with its vendors and customers.

Area of responsibility 4: Collaborate in creation of materials and processes for delivery of PV training.

Main responsibilities:

• Champion creation, maintenance, and/or delivery of PV training applicable to various audiences within Virbac ranging from Office Veterinary Team personnel to Sales team members.

• Collaborate to modify or adapt training for audiences outside Virbac (distributor representatives, veterinary customers, consumers)

• Collaborate closely with leaders and managers in Virbac Sales, Marketing, Technical Services, Regulatory and others as needed to ensure alignment of PV training with required goals and objectives of Commercial Operations.

Expected results: High-quality PV training is successfully delivered to all internal and external audiences in full alignment with Commercial Operations' goals and compliance standards.

Area of responsibility 5: Special Project Leadership and Support

Main responsibilities:

• As directed and agreed with Company Leadership, take on leadership or support roles for special projects.

Expected results: Help Virbac Corp. grow its business.

Requirements (Diploma and experience)

• Veterinarian currently licensed to practice in the United States (current license to practice in Texas a plus).

• At least 5 years in clinical veterinary practice with significant emphasis on internal medicine, parasitology, dermatology, and dental in companion animals. Food Animal experience is a plus.

• Interest and experience with exotic pets and/or industry experience are helpful but not required.

• Advanced education in animal science related field demonstrated through focus in medicine, pharmacology and/or regulatory area(s), OR in depth experience with pharmacovigilance and customer service in veterinary/animal health industry.

• Office based position in Westlake, Texas.

Skills

• Demonstrate drive and results orientation

• Analyze problems and situations

• Demonstrate the ability to anticipate and plan

• Communicate effectively

• Demonstrate teamwork and cross-functional cooperation

• Demonstrate ability to adapt and develop personal skills

• Demonstrate customer focus

• Previous supervisory or management experience and P&L responsibility