International PV Manager

International PV Manager - Vertex

The International Pharmacovigilance (PV) Manager is a pivotal role within the Global Patient Safety (GPS) team, responsible for ensuring compliance with PV regulations for Vertex products across the region. This position demands a high degree of independence, accountability, and regional regulatory expertise.

The Manager leads and maintains compliance with PV regulations, makes informed decisions within defined responsibilities, and escalates significant risks to International PV leadership. This non-promotional role aligns with the principles of pharmacovigilance and operates in a dynamic, multi-cultural environment.

• Responsibilities:
• Ensure alignment of assigned territory PV activities with global and local PV regulations.
• Lead contractual agreements to support local and regional PV regulatory obligations.
• Monitor evolving PV expectations and assess regulatory intelligence, driving appropriate actions.
• Evaluate and improve the Quality Management System, including localization.
• Author and review Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Maintain required PV documentation and provide oversight of PV activities by staff, vendors, and partners.
• Review PV metrics, compliance reports, and issue logs, escalating deviations as needed.
• Lead or contribute to vendor/partner meetings related to PV execution and compliance.
• Support health authority inspections and internal audits for assigned regional PV activities.
• Lead the build-out and maintenance of Vertex’s PV system in new markets.
• Represent GPS in patient safety matters and serve as the appointed Local Responsible Person for Pharmacovigilance (RPPV) or Qualified Person for Pharmacovigilance (QPPV), or deputy.
• Exercise defined decision-making authority for assigned regional PV compliance and oversight matters.
• Perform other duties as assigned.

Key Requirements: Collect, analyze, and utilize data and feedback to improve cross-functional relationships, working effectively and leading business initiatives. Demonstrate strong written and oral communication skills in English and Arabic, with a Saudi passport, and the ability to multi-task with a keen attention to detail. Possess a strong sense of responsibility, adaptability, and the capacity to work autonomously and in a team setting.