Veterinarian Pharmacovigilance

Denver, CO

The Veterinarian Pharmacovigilance is responsible for providing clinical oversight/support for research Equine care and use, medicine, disease diagnosis and experimental techniques. The role is also responsible for driving the regulatory process for products requiring Regulatory Agency’s approval by the US-FDA, the EU’s EMA among others, by ensuring that all necessary applications and the corresponding dossiers are prepared, published, and submitted on timely basis, as well as to handle all Regulatory Agency’s interactions on timely and priority basis. The role assists in developing and maintaining procedures and systems to ensure regulatory compliance such as Pharmacovigilance system. The task also consists of submission activities across all development programs and ensures the regulatory systems are fully validated and functional.

Date Posted:
11/17/2021
Salary:
Starting at $100,000

RESPONSIBILITIES:

  • Develop clinical trials for different treatments of varying ailments and illnesses for Equine Care.
  • Administer treatments for Equine Care.
  • Documenting treatment efficacy during the clinical trial.
  • The individual develops content and format for regulatory submissions and obtaining approvals supporting successful launches for the Company’s diagnostics and drug treatment products.
  • Generate regulatory reports and perform safety submissions as needed.
  • Maintain knowledge and understanding of safety-related regulations and guidelines.
  • Submits regulatory submissions and other regulatory documentation in support of business plan goals and objectives and in line with the current regulatory requirements.
  • Prepare, publish, and timely submit periodic reports and various responses to regulatory inquiries.
  • Serve as regulatory affairs representative on assigned teams to provide input for filing activities.
  • Ensure that compliant reporting systems are maintained, and timelines are communicated.
  • Follow-up to obtain required data for timely submission to the Regulatory authorities.
  • Maintain a basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope.

 

QUALIFICATIONS:

  • Must be a Doctor of Veterinary Medicine with at least two (2) years of work experience and/or training
  • Minimum of 2 years as a Veteran in a clinical environment
  • Knowledge of animal health regulations of major regulatory agencies (FDA, EPA, USDA, and/or EMA)
  • Minimum of 1 year of pharmacovigilance experience (pre-approval clinical trials)
  • Demonstrated knowledge of drug and/or biologic regulatory requirements associated with the US FDA and other international regulatory agencies’ requirements
  • Ability to work independently, prioritize work effectively and work successfully in a matrix team environment

 

BENEFIT SUMMARY:

Medical, Dental, Vision, Company Paid LI, AD&D, Matching 401K, Employee Assistance Program, Paid Time off, Tuition Reimbursement, and more!

PHM Brands is an equal opportunity employer and considers qualified applicants for employment without regard to sex, race, color, religion, ethnic or national origin, gender, sexual orientation, gender identity or expression, age, pregnancy, leave status, disability, veteran status, genetic information and/or any other characteristic or status protected by national, federal, state, or local law. ​

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