Pharmacovigilance Quality Assurance Principal Scientist

Job Purpose:

• Support Pharmacovigilance Management Systems for PV Operations.
• Create and maintain vendor organization records related to PV activities within the Quality Management System (QMS).
• Supports ensuring adverse event (AE) reporting requirements are clearly defined within contracts and agreements.

Key Responsibilities:

• Provide QA oversight for end‑to‑end PV activities: case processing, safety surveillance, risk management, and signal detection.
• Develop and implement global PV QA strategies and risk‑based audit programs aligned with FDA, EMA, MHRA, ICH, and other regulatory requirements.
• Author, review, and maintain PV‑related SOPs, WIs, and quality documentation.

Education Requirements:

• Degree in life sciences or medical related field or previous experience equating to educational requirements.
• An advanced degree in strategy, innovation or leadership is an advantage.

Job Related Experience:

• Experience in operational risk assessment, quality issue management, CAPA development, and audit preparation.
• Knowledge of PV vendor and contract management.
• Familiarity with global PV regulations (FDA, EMA, ICH).