Senior Consultant Pharmacovigilance SME

Overview

Critical Capabilities

• Strong understanding of pharmacovigilance principles, regulatory expectations, and operational best practices.
• Knowledge of adverse event intake, ICSR management, seriousness assessment, follow-up, reconciliation, MedDRA coding, quality control, and regulatory reporting considerations.
• Understanding of signal detection, signal validation, risk management, risk minimisation, periodic safety reporting, literature monitoring, safety governance, and PV system documentation.
• Familiarity with PV quality systems, SOPs, training, deviation management, CAPA, audits, vendor oversight, document control, inspection readiness, data integrity, and records retention.
• Ability to interpret and translate complex regulatory, operational, and healthcare requirements into practical assessment criteria, guidance, templates, and client-facing outputs.
• Strong consulting-style problem solving, with the ability to structure ambiguous issues and convert them into clear workplans, deliverables, and decisions.
• Experience supporting regulatory implementation, compliance assessment, maturity modelling, gap analysis, operating model design, or process improvement initiatives.
• Strong stakeholder engagement and facilitation skills, including the ability to work with public-sector, regulatory, pharmaceutical, healthcare, technology, and quality stakeholders.
• Ability to produce high-quality written outputs, including reports, frameworks, process documentation, guidance materials, training content, executive presentations, and decision papers.
• Strong project management discipline, including planning, action tracking, risk management, issue escalation, and delivery against timelines.
• Ability to work in a multi-stakeholder, cross-functional project environment involving PV, regulatory, quality, digital, data, and client teams.
• Cultural awareness and ability to operate effectively in UAE, GCC, or international healthcare and regulatory environments.