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Pharmacovigilance Compliance Analyst

2 months ago

Duluth, Minnesota, United States TalentBurst Full time

Position:
Pharmacovigilance Specialist

Location:
Remote

Duration: 12 Months

Work Schedule:
8 AM - 5 PM, Monday to Friday

Responsibilities:

This role requires the candidate to be present on-site at designated locations a minimum of two days per week.



Core Objective:

Ensure adherence to Pharmacovigilance regulations as mandated by relevant authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA, etc.) as outlined in corporate and BIAH PV Standard Operating Procedures, FDA 21 CFR, USDA 9 CFR, and current European legislation.

Evaluate, analyze, and authorize product/adverse event complaints for BIAH products distributed in the US, and report to necessary regulatory bodies as needed.

Provide assistance to Pharmacovigilance Management in areas such as Adverse Drug Event (ADE) analysis, PV trend monitoring, and signal detection.

Key Responsibilities:


Collaborates with Global PV management to uphold compliance with regulatory standards and BI protocols:

  • Oversees a backlog of PV case reports sourced from the EU Pharmacovigilance Database (Eudravigilance (EVVET)).
  • In conjunction with designated Specialists, imports cases directly from the EVVET into PV Works, managing these cases according to internal guidelines and global regulatory standards.
  • Reviews case details on individual reports or line listings as requested by Management and/or Local Pharmacovigilance contacts.
  • Updates all imported cases to align with BI data standards.
  • Assesses and verifies all complaints for accuracy and consistency in data, coding, and case evaluations, ensuring submission to relevant regulatory authorities.
  • Collaborates with Local Pharmacovigilance contacts to ensure case processing meets operational requirements.
  • Supports stakeholders with Pharmacovigilance reports as requested.

Independently applies fundamental scientific principles, conducts literature reviews, stays informed on current literature in the field, and participates in scientific conferences; demonstrates a contemporary level of technical expertise in the discipline.


Required Skills:

Leadership and Learning Competencies
Functional Expertise
Understanding of Pharmaceutical Life Cycle Process - Level 2, Demonstrating
Knowledge of Regulatory Standards & Compliance - Level 2, Demonstrating
Building Strategic Relationships - Level 1, Developing

Conflict Management - Level 2, Demonstrating
Negotiation Skills - Level 2, Demonstrating
Market Insight - Level 2, Demonstrating
Core Competencies
Business and Technical Acumen - Level 2, Demonstrating
Communication Skills - Level 2, Demonstrating
Customer Focus - Level 2, Demonstrating
Results Orientation - Level 2, Demonstrating
External Awareness - Level 1, Developing
Efficient Execution - Level 2, Demonstrating
Innovation and Adaptability - Level 2, Demonstrating
Commitment to Learning - Level 2, Demonstrating
Planning and Organizational Skills - Level 2, Demonstrating
Quality Focus/Business Process Excellence - Level 2, Demonstrating
Team Collaboration - Level 2, Demonstrating
Visionary Thinking - Level 1, Developing
Problem-Solving Skills - Level 2, Demonstrating
Continuous Improvement - Level 2, Demonstrating
Analytical Skills - Level 2, Demonstrating
Foundational Competencies
Accountability and Ownership
Integrity and Trust
Commitment to Diversity and Inclusion

Educational Qualifications:

Minimum Education/Degree Requirements*
A veterinary degree (DVM or VMD) from an accredited institution is required, along with
Three (3) years of experience in veterinary practice or in Pharmacovigilance, Pharmacoepidemiology, or a related field.
Previous experience in the pharmaceutical industry or drug safety/pharmacovigilance is preferred.

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