(Archived) Pharmacovililance and Regulatory Affairs Manager

Description

Reporting directly to the Vetoquinol USA Inc. Business Area Director for Scientific Affairs, the Vetoquinol USA Inc. Pharmacovigilance and Regulatory Affairs Manager is the single person accountable for all aspects of the Pharmacovigilance System for the USA affiliate. Working as part of the US Regulatory Affairs team they will be responsible for all pharmacovigilance reporting and submissions to relevant authorities to support a dynamic and diverse range of products on behalf of the business. This position will also serve as a source of veterinary expertise to strengthen regulatory submissions across the US regulatory affairs department and with other departments to address customer concerns and questions. This position may be based in Fort Worth, Texas or it may be remote, with travel required to meet business needs.

Essential Functions

Pharmacovigilance (PV) and Regulatory Affairs

• For any product which Vetoquinol USA Inc. is the product owner, the Pharmacovigilance and Regulatory Affairs Manager will be able to provide and take the following relevant adverse event or adverse drug experience information arising from the use of the product anywhere in the world:
  • An adverse event occurring in animals in the course of the use of an animal drug product by a veterinarian or by a livestock producer or other animal owner or caretaker.
  • Failure of a new animal drug to produce its expected pharmacological or clinical effect (lack of expected effectiveness).
  • An adverse event occurring in humans from exposure during manufacture, testing, handling, or use of a new animal drug.
  • Additional safety information necessary for the evaluation of the benefit and the risk of the Product(s)
• Ensure management of the communication with, and reimburements requests for, customers when an adverse event or adverse drug experience has occurred for a Vetoquinol USA Inc. customer
• Establish and maintain the Vetoquinol USA Inc. Pharmacovigilance (PV) System
  • Ensures that information about all adverse events or adverse drug reactions which are reported to any personnel of Vetoquinol is collected, collated and submitted to relevant authorities as required by regulation, guideline or policy
  • Establishes and maintains appropriate quality controls and SOPs to support the PV System which includes reports and database operations
  • Establishes and maintains appropriate contractual arrangements with Distribution In or Distribution Out partners and with any external contracts supporting PV system
  • Ensures the appropriate training of personnel involved in PV, including targeted training as needed for specific products
  • Ensure any delegation of these responsibilities are captured in writing
• This position will functionally report into the General Director for USA Inc. to provide the appropriate level of authority related to all PV matters
• This position will functionally report to the European Union – Qualified Person for PV (EU-QPPV) as part of the Vetoquinol GROUP PV network and will comply with all GROUP level PV reporting and training as per Corporate SOPs and Policies
• This position will also be networked within the US Regulatory Affairs department and may provide support or be assigned to:
  • Regulatory submissions which fall outside PV, specifically related to safety and efficacy of products which are commercialized or in development
  • The production of new or updated Safety Data Sheets for products
  • Management of commercial samples
  • Support for label changes and review
  • Support for business development Due Diligence, as requested
  • Specific technical or regulatory assignments as requested by Management

Planning

• Ensures short term and long-term planning of all activities related to PV within the department.
• Contributes to the Company’s annual budget process by defining requirements and needs

General/Administrative

• Supports the company vision and mission and demonstrates the corporate core values in all professional activities.
• Complies with all OSHA safety requirements, work rules and regulations.
• Compiles and maintains all required paperwork, records, documents, etc.
• Follows systems and procedures outlined in company policies or handbooks
• All other duties as requested by management.

Qualifications

Formal Education

• A DVM who is located within the USA is required for this position
• Additional certifications or degrees are welcome

Knowledge and Experience

• 1-3 Years’ experience with some aspect of pharmacovigilance or regulatory affairs
• Product sales and technical service veterinary customer experience is desired
• 5-10 Years’ experience in the animal health industry (may include clinical practice)
• Knowledge or experience with quality systems is desirable but not essential
• Having served as a people manger is desirable by not essential

Personal Attributes

• Exceptional organizational and time management skills
• Ability to work independently
• Ability to view, develop and implement long term strategies and processes
• Highly developed interpersonal skills, possessing an ability to work with a diverse population
• Attention to detail
• Desire to serve and achieve results