Manager - Pharmacovigilance

Ensure a compliant, efficient, and robust Pharmacovigilance (PV) system in Morocco, in line with national regulations and global pharmacovigilance standards.
Act as the single 24/7 point of contact with Moroccan health authorities (CAPM and DMP) for all safety-related matters and ensure effective collection, reporting, evaluation, and communication of product safety information to protect patient safety and maintain marketing authorization compliance.

Accountability Cluster

Major Activities / Tasks

Regulatory Liaison & Authority Interaction

• Act as the single 24/7 contact point for CAPM and DMP regarding product safety.
• Respond to safety-related requests from authorities within required timelines.
• Ensure compliance with Moroccan pharmacovigilance laws, guidelines, and authority expectations.

Safety Data Collection & Reporting

• Ensure intake, documentation, and transmission of all AEs, ADRs, special situations, pregnancies, product quality complaints with safety impact, and literature cases from Morocco.
• Ensure timely submission of ICSRs to CAPM and transmission to the global safety database.
• Oversee submission of PSURs, safety signals, and ad-hoc safety reports as per Moroccan requirements.

Oversight of Local PV System

• Maintain continuous oversight of the local pharmacovigilance system, ensuring compliance, effectiveness, and adequate resourcing.
• Monitor benefit–risk profiles of marketed products and ensure escalation of safety issues internally and externally.
• Oversee implementation of risk minimization measures and RMP commitments locally.

PV Quality System & Documentation

• Maintain the Local PSMF or Morocco local annex aligned with the Global PSMF.
• Ensure local SOPs and work instructions are current, compliant, and implemented.
• Ensure documentation control, archiving, reconciliation activities, CAPA management, audit and inspection readiness.

Training & Awareness

• Deliver, document, and track pharmacovigilance training for all local employees, distributors, partners, and third parties.
• Ensure ongoing PV awareness across all functions to guarantee timely reporting of safety information.

Signal Management & Safety Communication

• Contribute to local signal detection activities (trend analysis, literature review inputs) in line with global processes.
• Coordinate safety communications, DHPCs, urgent safety restrictions, and authority-mandated notifications.

Vendor, Distributor & Partner Oversight

• Ensure Safety Data Exchange Agreements (SDEAs) or PV clauses are in place with all partners and distributors.
• Conduct periodic oversight (KPIs, audits, follow-ups) of partner PV activities.

Audit, Inspection & Business Continuity

• Ensure readiness for authority inspections and internal audits. Lead responses to findings and corrective actions (CAPAs).
• Maintain 24/7 availability and ensure business continuity through a trained deputy/local back‑up.

Accountability for Drug Safety Governance

• Ensure all AEs/ADRs received by any local function are escalated within 24 hours to the Global Drug Safety team.
• Support follow‑up information collection from reporters and healthcare professionals.

• Managing strict regulatory timelines and 24/7 availability requirements alongside routine PV activities.
• Ensuring full PV compliance across distributors, partners, and third parties.
• Maintaining inspection readiness with evolving regulations and authority expectations.

Overcome by:
• Strong planning and prioritization
• Clear SOPs and escalation pathways
• Continuous training and partner oversight
• Close collaboration with global Drug Safety teams

Internal

External

• Global Drug Safety Team (daily/weekly) for case processing, PSURs, and signals
• Regulatory Affairs (monthly) for variation and safety commitments
• QA – QC – Production – RA - Medical, Marketing, Sales for PV awareness and AE reporting
• Quality & Compliance (as required)

• CAPM & DMP (as required) for safety reporting and regulatory interactions
• Healthcare Professionals (as needed) for follow-ups
• Distributors & Partners for PV compliance
• Auditors & Inspectors

• Ensure accurate accounting records
• Prepare accounting month end journals, –meeting day 4 deadline
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