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Pharmacovigilance Veterinarian

3 months ago

Duluth, United States SPECTRAFORCE Full time

Job Title: Pharmacovigilance Veterinarian

Duration: 12 Months

Location: Duluth, GA OR St. Joseph, MO

Schedule: 8-5 M-F

Note: This would be a site-based position and the candidate would be required to be on-site at one of the locations (Duluth or ST Joseph) a minimum of 2 days/week.

Pay Starts from $65/hr on W2 (Negotiable)


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 Company 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.


Duties:

Supports Global PV management in maintaining compliance with regulatory requirements and Company 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 manage these case 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
  • Update all import cases to meet Company standard of data
  • Reviews and evaluates all complaints for accurate and consistent data, coding and 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 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.