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 benefitrisk 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 backup.

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 followup 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

Decisions

Recommendations

Decisions related to local PV system implementation and compliance

Recommendations on safety actions and risk minimization measures to Country Head / Global PV

Decisions related to authority communication

and inspection readiness

Recommendations on CAPAs and process improvements

Decisions related to partner PV oversight

Advice on partner compliance and audit outcomes

Comments:

Educational qualifications:

• Degree in Pharmacy or Medicine (mandatory)

Relevant experience:

• • 35 years of experience in Pharmacovigilance or Regulatory Affairs
  • Strong knowledge of Moroccan PV regulations (CAPM / DMP) and global PV standards
  • Experience interacting with health authorities and managing inspections
  • Strong analytical documentation and communication skills
  • Fluency in French Arabic and English