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Pharmacovigilance Compliance Officer

2 months ago

Duluth, Minnesota, United States TalentBurst Full time

Title:
Pharmacovigilance Specialist

Location:
Remote or Hybrid

Duration: 12 Months

Shift:
Hours - 8-5 M-F

Responsibilities:

This position requires the candidate to be present on-site at designated locations a minimum of 2 days per week.



Primary Objective:

Ensures adherence to Pharmacovigilance regulations as mandated by various authorities, including but not limited to FDA, EMA, and other relevant bodies, in accordance with established corporate policies and standard operating procedures.

Evaluate, analyze, and validate product and adverse event reports for products distributed within the US, ensuring timely submission to regulatory agencies as necessary.

May assist Pharmacovigilance Management in the analysis of adverse drug events, trend analysis, and signal detection.

Key Responsibilities:


Aids Global Pharmacovigilance management in ensuring compliance with regulatory standards and internal procedures:

  • Oversees a queue of Pharmacovigilance case reports from the European Pharmacovigilance Database.
  • Collaborates with assigned specialists to import cases from the database into internal systems, managing these cases in line with regulatory requirements.
  • Reviews case details on individual reports or listings as requested by management.
  • Ensures all imported cases meet organizational data standards.
  • Assesses and verifies all complaints for accuracy, consistency, and compliance before submission to relevant authorities.
  • Coordinates with local pharmacovigilance teams to ensure case processing aligns with operational requirements.
  • Provides assistance to stakeholders regarding pharmacovigilance reports as needed.

Independently applies fundamental scientific principles, conducts literature reviews, stays updated on relevant scientific developments, and participates in scientific forums; demonstrates a contemporary level of expertise in the field.


Required Skills:

Leadership and Learning Competencies
Functional Expertise
Understanding of Pharmaceutical Lifecycle - Level 2, Demonstrating
Knowledge of Regulatory Compliance - Level 2, Demonstrating
Building Strategic Relationships - Level 1, Developing

Conflict Management - Level 2, Demonstrating
Negotiation Proficiency - 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 Assurance and 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 Responsibility
Integrity and Trustworthiness
Commitment to Diversity and Inclusion

Educational Qualifications:


Minimum Educational 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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