Veterinary Pharmacovigilance Specialist
2 weeks ago
Veterinary Pharmacovigilance Specialist
Location: Remote
Duration: Long-term Contract
Hours: Standard Business Hours
This position requires the selected candidate to engage in on-site activities at designated locations on a part-time basis.
Job Overview:
The role is pivotal in ensuring adherence to pharmacovigilance regulations set forth by relevant authorities, including but not limited to FDA, USDA-APHIS, EMA, and CFIA, in accordance with established corporate policies.
The incumbent will be responsible for:
- Evaluating and approving product and adverse event reports for veterinary products distributed in the market.
- Collaborating with Pharmacovigilance Management on adverse drug event analysis and signal detection.
Key Responsibilities:
- Support Global Pharmacovigilance management in upholding compliance with regulatory standards and internal procedures.
- Oversee a backlog of pharmacovigilance case reports sourced from the European Pharmacovigilance Database.
- Work alongside designated specialists to import cases into the internal system and manage them per regulatory guidelines.
- Review individual case reports and line listings as requested by management.
- Ensure all imported cases meet corporate data standards.
- Assess complaints for accuracy and consistency in data and coding before submission to regulatory bodies.
- Collaborate with local pharmacovigilance representatives to ensure case processing aligns with operational requirements.
- Assist stakeholders with pharmacovigilance reports as needed.
The candidate should demonstrate proficiency in scientific principles, conduct literature reviews, and maintain current knowledge in the field.
Core Competencies:
- Knowledge of Pharmaceutical Life Cycle Process
- Understanding of Regulatory Requirements & Compliance
- Effective Communication Skills
- Customer Orientation
- Results-Driven Approach
- Team Collaboration
Qualifications:
A Doctor of Veterinary Medicine (DVM or VMD) degree from an accredited institution is required, along with a minimum of three years of experience in veterinary practice or related fields such as pharmacovigilance or pharmacoepidemiology. Previous experience in the pharmaceutical industry or drug safety is preferred.
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