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Pharmacovigilance Veterinarian

1 month ago

Duluth, United States Aequor Full time

Pharmacovigilance Veterinarian

Location: St. Joseph, MO/Duluth GA

Duration: 12+ Months


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 BIAH 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 BI 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 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.


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


Minimum Education/Degree 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.