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Veterinary Pharmacovigilance Specialist
2 months ago
Contract Duration: 1 year, with a minimum of 2 days on-site per week. Compensation: $68.97 per hour.
Primary Responsibilities:
- Ensure adherence to Pharmacovigilance regulations set by relevant authorities, including but not limited to FDA, USDA-APHIS, EMA, and CFIA, in accordance with corporate and internal PV Standard Operating Procedures (SOPs), FDA 21 CFR, USDA 9 CFR, and current European legislation.
- Evaluate, analyze, and authorize product/adverse event complaints related to company products distributed in the US, and report to the necessary regulatory bodies as mandated.
- Support Pharmacovigilance Management in areas such as Adverse Drug Event (ADE) analysis, trend analysis, and signal detection.
- Assist Global Pharmacovigilance management in ensuring compliance with regulatory standards and internal protocols.
- Manage a backlog of Pharmacovigilance case reports sourced from the EU Pharmacovigilance Database (Eudravigilance (EVVET)).
- Collaborate with designated Specialists to import cases from EVVET into PVWorks, managing these cases in line with internal guidelines and global regulatory standards.
- Review case data on individual reports or line listings as requested by management and/or Local Pharmacovigilance (LPV) teams.
- Update all imported cases to align with internal data quality standards.
- Scrutinize and assess all complaints for accuracy and consistency in data, coding, case evaluations, and submissions to relevant regulatory authorities.
- Work alongside all LPVs to ensure that case processing complies with Organizational Processing Unit (OPU) requirements.
- Assist stakeholders with Pharmacovigilance reports as needed.
- Independently apply fundamental scientific principles, conduct literature reviews, stay informed about developments in the field, and participate in scientific conferences; demonstrate a contemporary level of technical expertise in the domain.
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 Proficiency - Level 2, Demonstrating
- Market Insight - Level 2, Demonstrating
- Core Competencies:
- Business and Technical Acumen - Level 2, Demonstrating
- Effective Communication - Level 2, Demonstrating
- Customer-Centric Approach - Level 2, Demonstrating
- Results Orientation - Level 2, Demonstrating
- External Perspective - Level 1, Developing
- Efficient Execution - Level 2, Demonstrating
- Innovation and Adaptability - Level 2, Demonstrating
- Commitment to Learning - Level 2, Demonstrating
- Analytical Problem Solving - Level 2, Demonstrating
- Foundational Competencies:
- Accountability and Ownership
- Integrity and Trustworthiness
- Commitment to Diversity and Inclusion
Educational Background:
- Veterinary degree (DVM or VMD) from an accredited institution is mandatory.
- A minimum of three (3) years of experience in veterinary practice or in Pharmacovigilance, Pharmacoepidemiology, or a related field is required.
- Previous experience in the pharmaceutical industry or in drug safety/pharmacovigilance is preferred.
