Quality and Safety Specialist – Senior Level

Are you an experienced pharmacovigilance quality professional with a strategic mindset and deep regulatory knowledge? This permanent senior-level Quality and Safety Specialist position offers the opportunity to take ownership of global compliance standards and inspection readiness for a leading pharmaceutical organisation.

THE COMPANY

This innovative pharmaceutical company is committed to advancing patient safety through cutting-edge therapeutic development and global regulatory excellence. Operating across international markets, the organisation integrates quality, pharmacovigilance, and medical affairs into a cohesive system built for inspection readiness and long-term sustainability. They have a strong track record of success having marketed drugs globally, with a strong pipeline in both preclinical and clinical stages.

As part of a cross-functional quality team, you will play a pivotal role in embedding a robust quality culture while driving forward the organisation’s Good Pharmacovigilance Practice (GVP) framework and global procedural standards.

THE ROLE

In this role, you will take system-level ownership of GVP quality across both internal functions and external partners, overseeing compliance, audit execution, and regulatory engagement. Your remit will span from SOP governance and audit readiness to leading the organisation’s response to evolving regulatory expectations.

You will work closely with Global Medical Affairs, Regulatory Affairs, Clinical Development, and Safety teams to deliver a harmonised approach to GVP quality and pharmacovigilance excellence.

KEY RESPONSIBILITIES

• Lead the development, maintenance, and harmonisation of SOPs and quality systems relating to pharmacovigilance.
• Design and oversee execution of GVP audit strategies, including external consultant coordination and CRO/vendor oversight.
• Act as the primary quality representative during regulatory inspections (GVP, DM), ensuring end-to-end readiness across all pharmacovigilance and safety systems.
• Own the development of risk-based quality management plans and proactively identify and mitigate potential compliance gaps.
• Drive implementation and tracking of corrective and preventive actions (CAPAs), following audits and inspections.

ABOUT YOU

You’ll be well suited to this role if you bring:

• At least 8 years of experience in pharmacovigilance quality roles within the pharmaceutical or life sciences industry.
• Advanced knowledge of GVP and global regulatory frameworks.
• Demonstrated experience leading audits, managing inspection readiness, and engaging directly with regulators.
• Proven ability to influence stakeholders and embed a culture of quality across matrixed teams.

If you're ready to take a leading role in shaping GVP quality strategy at a global level, apply now.

This is your opportunity to make a lasting impact on pharmacovigilance quality worldwide.