Pharmacovigilance Specialist - Contract - TalentBurst, Inc.
Duluth, GA
About the Job
Title: Pharmacovigilance Specialist
Location: St. Joseph, MO 64506 or Duluth, GA 30096
Duration: 12 Months
Shift: Hours – 8-5 M-F
Duties:
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 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.
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:
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.
Location: St. Joseph, MO 64506 or Duluth, GA 30096
Duration: 12 Months
Shift: Hours – 8-5 M-F
Duties:
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 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.
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:
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.
Source : TalentBurst, Inc.
