International PV Manager

About the role

The International Pharmacovigilance (PV) Manager joins the Global Patient Safety team to ensure compliance with PV regulations for Vertex products across the region. Operating with a high degree of independence, the manager applies regional regulatory knowledge to practical execution and escalates material risks to International PV leadership.

Key responsibilities

• Ensure regional PV activities and GPS procedures align with global and local regulations.
• Lead coordination and finalization of contractual agreements supporting local and regional PV obligations.
• Maintain up‑to‑date knowledge of evolving PV expectations and assess regulatory intelligence for the region.
• Evaluate and improve the Quality Management System for regional activities, including localization.
• Author and review SOPs, work instructions, and required PV documentation (PSMF sections, annexes, training records).
• Provide oversight of PV activities performed by staff, vendors, and partners, monitoring performance and managing risks.
• Review PV metrics, compliance reports, and issue logs; escalate deviations, risks, or delays as needed.
• Support regulatory inspections and internal/external audit activities.

Required profile

• Saudi passport holder.
• Ability to multitask with strong attention to detail.
• Excellent written and oral communication skills in English and Arabic.
• Strong sense of responsibility; capable of autonomous work and effective teamwork.
• Understanding of established procedures and ability to communicate them.
• Adaptability to changing priorities and workload management.

Required skills