Senior Consultant Pharmacovigilance SME

Sia

Job Description

Roles & Responsibilities

Desired Candidate Profile

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.

Qualifications

• Bachelor s degree in pharmacy, medicine, life sciences, biomedical sciences, public health, healthcare management, regulatory affairs, or a related field.
• Significant professional experience in pharmacovigilance, drug safety, regulatory affairs, clinical safety, healthcare quality, life sciences compliance, or related healthcare disciplines.
• Demonstrated experience supporting pharmacovigilance systems, PV operations, PV compliance, PV quality systems, safety reporting, or regulatory readiness activities.
• Strong understanding of global pharmacovigilance standards and recognised international PV guidance and best practices.
• Experience developing, reviewing, or implementing PV policies, SOPs, process maps, guidance documents, assessment tools, quality documentation, or training materials.
• Experience working with or for health regulators, ministries of health, public health authorities, pharmaceutical companies, CROs, hospitals, healthcare consulting firms, or life sciences organisations.
• Strong written and verbal communication skills, including the ability to produce client-ready deliverables, technical summaries, executive presentations, training materials, and stakeholder communications.
• Experience working in the UAE, GCC, or broader Middle East healthcare or life sciences environment.
• Familiarity with healthcare regulatory environments and public-sector healthcare transformation programmes.
• Experience supporting public-sector healthcare, regulatory authority, or national health-system strengthening projects.
• Relevant professional certifications in pharmacovigilance, regulatory affairs, quality, clinical research, project management, or related disciplines are desirable but not mandatory.
• Arabic language capability is advantageous but not required, unless specified by client or project requirements.

Professional Competencies

• Strategic thinker with the ability to connect pharmacovigilance requirements to broader healthcare system, regulatory, operational, and sector development objectives.
• Structured problem solver who can break down complex regulatory and operational topics into practical components, clear recommendations, and actionable deliverables.
• Client-service oriented, with strong judgment, responsiveness, and commitment to delivering high-quality outcomes for the client and project stakeholders.
• Delivery-focused and accountable, with a proactive approach to identifying risks, resolving issues, and maintaining momentum.
• Adaptable and comfortable working in a fast-paced consulting or project environment with evolving requirements and stakeholder needs.

AI Fluency

• Demonstrated AI fluency and comfort using AI-enabled tools to improve regulatory research, pharmacovigilance analysis, documentation, synthesis, presentation development, project delivery, and internal operations.
• Ability to assess how AI, data analytics, automation, and digital tools can support pharmacovigilance compliance assessment, regulatory requirement mapping, gap analysis, dashboarding, reporting, and knowledge management.
• Comfort working with data, dashboards, reporting outputs, technology-enabled workflows, and digital assessment tools.

Work Authorization / Location Preference

• Preference will be given to candidates already or willing to be based in the Abu Dhabi, UAE.
• Candidates must have, or be eligible to obtain, the appropriate work authorization for the UAE.
• Ability to travel as needed for client meetings, workshops, stakeholder engagement sessions, training activities, testing, and project delivery.
• Flexibility to work across remote and in-person delivery models, with regular availability for client and stakeholder engagement.