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Title

Veterinarian Pharmacovigilance 

EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
 
Full-Time/Part-Time -unspecified-  
Description

Hours – 8-5 MF

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.


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 BIAH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations.
  • Review, Assess and approve product/adverse event complaints for 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:
    -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
  • -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.
 
Location Duluth, GA  

This position is currently not accepting applications.

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