Drug Monitoring Specialist
Khobar
Job description
The Drug Monitoring Specialist supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing pharmacovigilance activities in Saudi Arabia. The role ensures compliance with legal, regulatory, quality and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system. Serves as backup Affiliate Safety Representative and National Qualified Person for Pharmacovigilance Deputy, staying continuously ready to act. Acts as the single local pharmacovigilance contact for Saudi health authorities 24/7, influences quality system performance, and ensures adherence to Saudi Good Pharmacovigilance Practice. Oversees the pharmacovigilance system, develops local procedures, supports adverse event intake, processing and reporting, and advises cross‑functional teams on safety matters
Requirements
- Proficient in written and spoken English
- Proficient in written and spoken Arabic
- Bachelor's degree in pharmacy or medicine
- At least two years of experience in pharmacovigilance in the pharmaceutical industry
- Theoretical and practical knowledge of pharmacovigilance activities
- Experience with adverse event and individual case safety report processes, periodic or aggregate reporting, risk management, pharmacovigilance quality systems, training, audits or inspections and regulatory compliance
- Sound knowledge of Saudi pharmacovigilance legislation and Good Pharmacovigilance Practice requirements
- Documented training to oversee and support an effective local pharmacovigilance system
- Ability to understand product safety profiles, emerging safety concerns and benefit‑risk information
- Excellent written and verbal communication and presentation skills
- Strong planning, organization and prioritization skills
- Sound judgment, attention to detail and sense of urgency
- Strong scientific acumen and ability to apply scientific and regulatory concepts
Skills
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