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Clinical Veterinarian
2 months ago
Working Hours: 8 AM - 5 PM, Monday to Friday
Position Overview: This role requires the candidate to be present at one of the designated locations at least two days per week.
Primary Responsibilities:
- Ensure adherence to Pharmacovigilance regulations as mandated by relevant authorities including FDA, USDA-APHIS, EMA, and CFIA, in accordance with corporate and Client PV Standard Operating Procedures (SOPs).
- Evaluate and authorize product and adverse event complaints related to Client products distributed in the United States, ensuring timely submission to the necessary regulatory bodies.
- Provide assistance to Pharmacovigilance Management in areas such as Adverse Drug Event (ADE) analysis, trend evaluation, and signal detection.
Key Duties:
Support Global Pharmacovigilance Management in maintaining regulatory compliance:
- Oversee a backlog of Pharmacovigilance case reports sourced from the EU Pharmacovigilance Database (Eudravigilance).
- Collaborate with designated specialists to import cases from Eudravigilance into the internal system, managing these cases in line with established guidelines and global regulatory standards.
- Review case details on individual reports or line listings as requested by management.
- Ensure all imported cases comply with Client data standards.
- Assess and verify all complaints for accuracy and consistency in data, coding, and case evaluations before submission to relevant authorities.
- Work closely with all local pharmacovigilance representatives to ensure case processing aligns with operational requirements.
- Assist stakeholders with Pharmacovigilance reports as needed.
- Independently apply fundamental scientific principles, conduct literature reviews, and stay updated on developments in the field while attending relevant scientific conferences.
Required Skills:
- Leadership and Learning Competencies
Functional Competencies:
- Understanding of Pharmaceutical Life Cycle Process - Level 2, Demonstrating
- Knowledge of Regulatory Requirements & Compliance - Level 2, Demonstrating
- Building Strategic Relationships – Level 1, Developing
- Conflict Management - Level 2, Demonstrating
- Negotiation Skills - Level 2, Demonstrating
- Market Insight - Level 2, Demonstrating
Core Competencies:
- Business and Technical Acumen - Level 2, Demonstrating
- Effective Communication - Level 2, Demonstrating
- Customer Focus - Level 2, Demonstrating
- Results Orientation - Level 2, Demonstrating
- External Awareness - Level 1, Developing
- Efficient Execution - Level 2, Demonstrating
- Innovation and Adaptability - Level 2, Demonstrating
- Commitment to Learning - Level 2, Demonstrating
- Organizational Skills - Level 2, Demonstrating
- Quality Assurance and Process Excellence - Level 2, Demonstrating
- Collaboration and Teamwork - Level 2, Demonstrating
- Visionary Thinking - Level 1, Developing
- Problem-Solving Abilities - Level 2, Demonstrating
- Continuous Improvement - Level 2, Demonstrating
- Analytical Skills - Level 2, Demonstrating
Foundational Competencies:
- Accountability and Ownership
- Integrity and Trustworthiness
- Commitment to Diversity and Inclusion
Educational Requirements:
- Veterinary degree (DVM or VMD) from an accredited institution.
- A minimum of three years of experience in veterinary practice or in the fields of Pharmacovigilance or Pharmacoepidemiology.
- Previous experience in the pharmaceutical industry or in drug safety/pharmacovigilance is preferred.