Job description

At Sia, we are looking for a highly experienced and motivated Senior Consultant – Pharmacovigilance SME to support the delivery of strategic pharmacovigilance and regulatory transformation engagements across the healthcare and life sciences sector.

The role requires a strong blend of pharmacovigilance subject matter expertise, regulatory and healthcare-sector knowledge, consulting-style project delivery capability, and stakeholder management. The successful candidate will be able to translate complex pharmacovigilance and regulatory expectations into practical frameworks, processes, documentation, tools, training materials, and client-ready deliverables.

The ideal candidate will bring hands-on experience in pharmacovigilance, drug safety, regulatory compliance, safety reporting, PV quality systems, risk management, and PV operating model design or improvement. They will be comfortable working with clients, regulators, pharmaceutical companies, healthcare organizations, and cross-functional project teams.

The Pharmacovigilance Manager will play a central role in ensuring that PV-related content, assessment logic, stakeholder materials, training outputs, and project deliverables are technically robust, practical, and aligned with the client’s expectations.

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.