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Veterinary Pharmacovigilance Specialist

2 months ago

Saint Joseph, Missouri, United States Planet Pharma Full time

Contract Type: 1 year contract, minimum 2 days on site/week, Pay $68.97/hr

Position Overview:

The primary responsibility of this role is to ensure adherence to Pharmacovigilance regulations set forth by relevant authorities, including but not limited to FDA, USDA-APHIS, EMA, and CFIA. This is achieved through the implementation of corporate and internal Pharmacovigilance Standard Operating Procedures (SOPs) and compliance with applicable regulations.

Key Responsibilities:

  • Evaluate and authorize product/adverse event complaints for company products distributed in the US, ensuring timely submission to regulatory bodies as required.
  • Support Pharmacovigilance Management in areas such as Adverse Drug Event (ADE) analysis, trend evaluation, and signal detection.
  • Assist Global Pharmacovigilance management in maintaining compliance with both regulatory mandates and internal processes.
  • Manage a queue 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 accordance with internal guidelines and global regulatory standards.
  • Conduct reviews of case information on individual reports or line listings as requested by management.
  • Ensure all imported cases meet internal data standards.
  • Assess and verify all complaints for accuracy, consistency in data, coding, case evaluations, and submissions to relevant regulatory authorities.
  • Work closely with Local Pharmacovigilance Representatives (LPVs) to ensure compliance with case processing requirements.
  • Provide assistance to stakeholders with Pharmacovigilance reports as needed.
  • Independently apply fundamental scientific principles, conduct literature reviews, stay updated on relevant literature, and participate in scientific conferences, demonstrating a high level of technical expertise in the field.

Required Skills:

  • Leadership and Learning Competencies
  • Functional Competencies
  • Understanding of Pharmaceutical Life Cycle Process - Level 2
  • Knowledge of Regulatory Requirements & Compliance - Level 2
  • Building Strategic Relationships – Level 1
  • Conflict Management - Level 2
  • Negotiation Skills - Level 2
  • Market Awareness - Level 2
  • Core Competencies:
  • Business and Technical Acumen - Level 2
  • Effective Communication - Level 2
  • Customer Focus - Level 2
  • Results Orientation - Level 2
  • External Perspective - Level 1
  • Efficient Execution - Level 2
  • Innovation and Adaptability - Level 2
  • Commitment to Learning - Level 2
  • Planning and Organizational Skills - Level 2
  • Quality Focus/Business Process Excellence - Level 2
  • Team Collaboration - Level 2
  • Problem-Solving Abilities - Level 2
  • Analytical Thinking - Level 2
  • 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 (3) years of experience in veterinary practice or in Pharmacovigilance, Pharmacoepidemiology, or a related field.
  • Prior experience in the pharmaceutical industry or drug safety/pharmacovigilance is preferred.