Pharmacovigilance Veterinarian
3902 Gene Field Road Saint Joseph, MO 64506 US
Job Description
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 internal 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.
- Supports Global PV management in maintaining compliance with regulatory requirements and internal 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 manages these cases 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.
- Updates all import cases to meet internal standards of data.
- Reviews and evaluates all complaints for accurate and consistent data, coding, 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 the 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.
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