Pharmacovigilance Specialist

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.

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.

-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 PV Works, 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

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.