Local Case Intake Advisor – GBS Patient Safety (One-Year Fixed Term)

About the role

This one‑year fixed‑term position supports the GBS Patient Safety team in Egypt by acting as the local point of contact for individual case safety report (ICSR) intake, processing and submission. You will bridge frontline insights with global pharmacovigilance standards to ensure timely, compliant actions that protect patients.

Key responsibilities

• Manage end‑to‑end intake, assessment and processing of safety data from clinical and post‑marketing sources, including literature.
• Provide prompt support for health‑authority queries and ensure on‑time submission of ICSR, SUSAR, PBRER, DSUR, signals and risk‑management plans.
• Contribute to local pharmacovigilance Quality Management System implementation, including document control, training, incident reporting and audit readiness.
• Act as primary liaison between local business units and Patient Safety, offering safety expertise to Marketing, Sales, Regulatory and Medical Affairs.
• Identify product quality and security issues, collect information for adverse event reporting.
• Lead data reconciliations, perform literature searches and screen regulatory databases for adverse events.
• Conduct manual follow‑up with healthcare professionals and maintain patient safety documentation.
• Operate global Patient Safety systems (e.g., Argus, VQV, ERV, ECMS) and support audit/inspection activities.

Required profile

• Experience in pharmacovigilance or patient safety case intake and processing.
• Familiarity with regulatory requirements for ICSR, SUSAR, PBRER and DSUR submissions.
• Ability to work independently while collaborating across cross‑functional teams.

Required skills

• Proficiency with Argus, VQV, ERV and ECMS systems.
• Literature searching and data reconciliation.
• Knowledge of pharmacovigilance quality management processes.