Overview

Manager – Pharmacovigilance Jobs in Rabat, Rabat-Salé-Kénitra, Morocco at Cipla Africa

Title: Manager – Pharmacovigilance

Company: Cipla Africa

Location: Rabat, Rabat-Salé-Kénitra, Morocco

Jub Porpose

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.

  • Organizational Chart
  • Key Accountabilities

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.
  • Major Challenges
  • 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
  • Key Interactions

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
  • Dimensions
  • Ensure accurate accounting records
  • Prepare accounting month end journals, –meeting day 4 deadline
  • Key Decisions:

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

  • Skills & Knowledge

Educational Qualifications

  • Degree in Pharmacy or Medicine (mandatory)

Relevant Experience

    • 3–5 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

Apply

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