Senior Pharmacovigilance Specialist

About the role

Abbott is seeking a Senior Pharmacovigilance Specialist to join its Established Pharmaceuticals Division in Tunisia. The role will act as the Affiliate Safety Representative for the French Africa Cluster and provide backup for the English Africa Cluster, ensuring compliance with internal policies and local regulations for both investigational and registered products.

Key responsibilities

• Serve as the local Qualified Person for Pharmacovigilance (QPPV) on a 24/7/365 basis.
• Maintain the Affiliate PV system, country chapter, procedures, forms, and templates.
• Plan and execute business continuity measures for pharmacovigilance activities.
• Receive, record, reconcile, and archive safety information, including literature and health‑authority screening.
• Prepare local periodic safety reports and Risk Management Plans.
• Submit safety information to regulatory authorities.
• Provide basic PV training to local EPD staff.
• Manage out‑of‑office coverage and ensure continuous safety data capture.
• Negotiate and implement local commercial pharmacovigilance agreements.
• Support due‑diligence activities for product acquisitions.

Required profile

• Extensive experience in pharmacovigilance within the pharmaceutical industry.
• Strong knowledge of local and international regulatory requirements for drug safety.
• Ability to act as a QPPV and handle 24/7 safety responsibilities.
• Excellent communication skills to interact with health authorities and internal teams.
• Proven ability to develop and maintain PV processes, documentation, and training.

Required skills

• Pharmacovigilance systems management.
• Regulatory safety submission.
• Risk Management Plan development.
• Safety data reconciliation and archiving.

What we offer

• Career development within a global healthcare leader.
• Access to international growth opportunities.
• Recognition as a top employer for diversity and inclusion.
• Supportive environment for work‑life balance.