Pharmacovigilance Manager

About the role

The Pharmacovigilance Manager will ensure a compliant, efficient, and robust PV system in Morocco, aligning with national regulations and global standards. The role serves as the 24/7 single point of contact with Moroccan health authorities for all safety‑related matters.

Key responsibilities

• Act as the sole 24/7 liaison with CAPM and DMP, responding to authority requests within required timelines.
• Collect, document, and transmit all adverse events, special situations, pregnancies, product quality complaints, and literature cases from Morocco.
• Submit individual case safety reports (ICSRs) to CAPM and ensure timely entry into the global safety database.
• Oversee local PV system performance, benefit‑risk monitoring, and implementation of risk minimisation measures.
• Maintain the local PSMF and SOPs, ensuring documentation control, archiving, CAPA management, and audit readiness.
• Deliver and track pharmacovigilance training for employees, distributors, partners, and third parties.
• Contribute to signal detection activities, coordinate safety communications, and manage urgent safety restrictions.
• Ensure safety data exchange agreements with partners, conduct KPI monitoring, audits, and follow‑ups.
• Lead preparation for authority inspections, internal audits, and business continuity planning.

Required profile

• Proven experience in pharmacovigilance, preferably within the Moroccan regulatory environment.
• Strong knowledge of Moroccan PV laws, guidelines, and global pharmacovigilance standards.
• Ability to manage 24/7 contact responsibilities and coordinate cross‑functional safety activities.
• Excellent documentation, audit, and risk‑management capabilities.

Required skills