Pharmacovigilance Specialist - NQPPV Backup (Saudi National)
Core
Supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing affiliate pharmacovigilance activities in Saudi Arabia, ensuring legal, regulatory, quality, and ethical responsibilities for patient safety.
Role type
National Qualified Person for Pharmacovigilance (QPPV) Deputy / Backup
Builds
An effective local pharmacovigilance system compliant with Saudi Good Pharmacovigilance Practice requirements
Domain
Healthcare / Pharmaceutical Regulatory Compliance
Deliverable
client delivery
Required skills
Pharmacovigilance system oversight, regulatory compliance, safety data reporting, audit coordination, training management, risk assessment, procedure development, stakeholder liaison
Preferred skills
Medical expertise, knowledge of Saudi health authority requirements, experience with safety databases and validation
Technologies
Pharmacovigilance System Master File, safety databases, audit management systems
Responsibilities
Act as National QPPV Deputy and back-up contact for Saudi health authority; oversee local pharmacovigilance system performance and quality; develop and maintain local PV procedures; manage adverse event intake, processing, and reporting; support audits and inspections; coordinate training for PV personnel; ensure compliance with regulatory timelines and data accuracy.
Seniority
Senior, hands-on IC
