[Hiring] Head of Pharmacovigilance Operations @Arriello Ireland Limited

Role Description

We are seeking an experienced and strategic Head of Pharmacovigilance (PV) Operations to lead our global safety operations and drive excellence across end-to-end pharmacovigilance delivery. This is a senior leadership role responsible for ensuring the highest standards of patient safety, regulatory compliance, and operational performance across all PV activities. You will play a pivotal role in shaping the future of PV operations through innovation, transformation, and strong cross-functional leadership.

As Head of PV Operations, you will:

• Provide strategic leadership and oversight of global PV operations, including case management and end-to-end safety processes.
• Ensure compliant, high-quality, and timely processing of safety data in line with global regulatory requirements.
• Drive operational excellence through continuous improvement, automation, and process optimisation initiatives.
• Lead organisational transformation, including outsourcing strategies and technology adoption to enhance efficiency and scalability.
• Oversee PV vendors and partners, ensuring performance, quality, and compliance standards are met.
• Establish and monitor KPIs, dashboards, and performance metrics to support data-driven decision making.
• Collaborate with cross-functional stakeholders including Clinical, Regulatory, Medical Affairs, Quality, and IT.
• Ensure inspection readiness and support audits and regulatory inspections globally.
• Build, lead, and develop a high-performing PV operations team, fostering a culture of excellence and accountability.

Qualifications

• Extensive experience in pharmacovigilance / drug safety within the pharmaceutical or biotech industry.
• Proven leadership experience managing global PV operations and teams.
• Strong knowledge of global PV regulations (e.g. FDA, EMA, ICH, GVP).
• Experience in case processing, safety systems, and vendor management.
• Track record of driving process improvement, transformation, and operational efficiency.
• Excellent stakeholder management and communication skills.
• Degree in Life Sciences, Pharmacy, Medicine, or related field (advanced degree preferred).

Benefits

• Work remotely while contributing to a global life sciences consultancy.
• Lead quality operations that directly influence patient safety and regulatory compliance.
• Collaborate in a multicultural, inclusive, and innovative environment.
• Enjoy opportunities for career progression, professional development, and international exposure.
• Flexible Work Options: Remote working flexibility to support your lifestyle.
• Generous Time Off: Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
• Home Office Support: Get support to create a productive home office setup.
• Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.