Pharmacovigilance Veterinarian

Job Title: Pharmacovigilance Veterinarian

Duration: 12 Months

Location: Duluth, GA OR St. Joseph, MO

Schedule: 8-5 M-F

Note: This would be a site-based position and the candidate would be required to be on-site at one of the locations (Duluth or ST Joseph) a minimum of 2 days/week.

Pay Starts from $65/hr on W2 (Negotiable)

Basic purpose of the job:

• Ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc.) as described in the corporate and Company PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations.
• Review, Assess and approve product/adverse event complaints for Company products manufactured or sold in the US, and submit to appropriate authorities as required.
• May provide support to Pharmacovigilance (PV)Management in the area of ADE analysis, PV trending and/or signal detection.

Duties:

Supports Global PV management in maintaining compliance with regulatory requirements and Company procedures:

• Manages a backlog of PV case reports originating from the EU Pharmacovigilance Database (Eudravigilance (EVVET)).
• Together with assigned Specialists, imports cases directly from the EVVET into PVWorks, and manage these case according to internal guidance and global regulatory requirements.
• Reviews case information on individual case reports or line listings as requested by Management and/or LPVs
• Update all import cases to meet Company standard of data
• Reviews and evaluates all complaints for accurate and consistent data, coding and case assessments and submission to applicable regulatory authorities.
• Works with all LPVs to ensure case processing meets OPU requirements.
• Assists stakeholders with PV reports as requested.
• Independently applies basic scientific principles, performs literature searches, keeps abreast of literature in own field and attends scientific meetings; demonstrates a contemporary level of technical proficiency in field.

Skills:

Lead & Learn & Leadership Competencies

Functional Competencies

• Knowledge of Pharmaceutical Life Cycle Process - Level 2, Demonstrating
• Knowledge of Regulatory Requirements & Compliance - Level 2, Demonstrating
• Leveraging strategic relationships – Level 1, Developing
• Managing Conflict - Level 2, Demonstrating
• Negotiation Skills - Level 2, Demonstrating
• Market knowledge - Level 2, Demonstrating
• Core Competences
• Business and Technical Knowledge - Level 2, Demonstrating
• Communication - Level 2, Demonstrating
• Customer Orientation - Level 2, Demonstrating
• Delivering Results - Level 2, Demonstrating
• External Focus - Level 1, Developing
• Fast and Focused Execution - Level 2, Demonstrating
• Innovation and Change – Level 2, Demonstrating
• Lives Lead & Learn - Level 2, Demonstrating
• Planning & Organization - Level 2, Demonstrating
• Quality Orientation/Bus Process Excellence - Level 2, Demonstrating
• Teamwork and Collaboration - Level 2, Demonstrating
• Winning Vision – Level 1, Developing
• Problem Solving - Level 2, Demonstrating
• Leveraging Strategic Relationships - Level 2, Demonstrating
• Continuous Learning – Level 2, Demonstrating
• Analytical Thinking - Level 2, Demonstrating
• Foundational Competencies
• Accountability and Ownership
• Integrity and Trust
• Values Diversity and Inclusion

Education:

• Veterinary degree(DVM or VMD) required from an accredited veterinary school with Three (3)Years of veterinary practice experience or Pharmacovigilance, Pharmacoepidemiology or related field experience.
• Previous pharmaceutical industry or drug safety/pharmacovigilance experience preferred.