Pharmacovigilance Specialist & QPPV – KSA & NDM

About the role

The Pharmacovigilance Specialist will act as the Qualified Person for Pharmacovigilance (QPPV) and serve as the single point of contact with Saudi Arabian authorities for products where Acino and Amoun are Marketing Authorization Holders. The role includes maintaining the PV quality management system, ensuring compliance with internal policies, and coordinating safety‑related communications.

Key responsibilities

• Represent the MAH in all safety activities and act as the primary PV contact for distributors, SFDA, and inspections, available 24 hours.
• Oversee the PV system and implement SOPs across KSA and NDM markets (Morocco, Libya, Yemen), ensuring compliance with global and local regulations.
• Establish and maintain the local PV Quality Management System, including master documents, PSSF, SOPs, and submissions required by national law and GVP.
• Prepare and distribute submission plans for PSURs, RMPs, DHCPs, and PSMFs/PSSFs, and monitor implementation of risk management measures.
• Conduct PV due‑diligence on distributors and service providers, create Safety Data Exchange Agreements, and support internal and external audits.

Required profile

• University degree in Pharmacy, Medicine, Life Sciences or related field.
• 2‑5 years of PV experience in the pharmaceutical industry, including experience as QPPV in KSA.
• Strong knowledge of SFDA PV regulations and Arab GVP guidelines.
• Fluent English (oral and written) and ability to manage documentation and deadlines.

Required skills

• SFDA PV regulations
• EMA GVP guidelines
• ICSR management
• PSUR/RMP preparation
• Risk management and signal detection
• Safety data exchange
• PV system oversight and SOP development
• Inspection readiness