Pharmacovigilance Veterinarian

Duties:

·      Ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc.)as described in the corporate and client PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations.

·      Review, Assess and approve product/adverse event complaints for client 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.

· Supports Global PV management in maintaining compliance with regulatory requirements and client 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 cases 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 BI 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.

Requirements:

·      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