Senior Pharmacovigilance Specialist

Responsibilities

• Serve as the local QPPV and Affiliate Safety Representative (ASR) for Viatris in KSA
• Organize, implement, and maintain the Affiliate Pharmacovigilance (PV) system to ensure compliance with local and global regulations
• Manage Individual Case Safety Report (ICSR) processes, including receipt, documentation, tracking, and forwarding to global teams
• Oversee safety data collection for clinical trials, epidemiological programs, and non-interventional studies
• Monitor local medical literature and social media for safety information and ensure proper reconciliation
• Lead the implementation of PV requirements for regional distributors through training and follow-ups
• Manage periodic safety reporting (PSUR) in liaison with local regulatory affairs
• Act as the primary affiliate contact for internal PV audits and regulatory authority inspections
• Ensure local implementation and tracking of Risk Management Plans (RMPs)
• Maintain PV business continuity plans and ensure annual testing and documentation

Requirements

• Bachelor's or Master's degree in Medicine, Pharmacy, or Life Sciences
• Saudi National
• Valid license from the Saudi Commission for Health Specialties (SCFHS)
• Completion of mandatory PV training from an SFDA-recognized provider
• Minimum of 3 years of experience in the pharmaceutical industry
• Minimum of 2 years of dedicated pharmacovigilance experience
• Fluent English communication skills
• Proficiency in computer skills and strong organizational abilities

About the Company

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. With a mission to empower people worldwide to live healthier at every stage of life, we provide access to high-quality medicines to approximately 1 billion patients annually.