Senior Pharmacovigilance Specialist – Affiliate Safety Representative

About the role

Abbott is seeking a highly motivated Senior Pharmacovigilance Specialist to serve as the Affiliate Safety Representative in Tunisia. The role ensures that all pharmacovigilance activities for Abbott’s registered and investigational medicinal products comply with local regulatory requirements and the company’s global standards.

Key responsibilities

• Act as the local Affiliate Safety Representative (ASR) and Local Safety Responsible (LSR).
• Maintain local pharmacovigilance procedures, documentation, and compliance requirements.
• Ensure timely receipt, recording, reconciliation, and reporting of safety information.
• Conduct safety surveillance activities, including literature and health authority website monitoring.
• Prepare and support local periodic safety reports and Risk Management Plans.
• Manage regulatory submissions related to pharmacovigilance activities.
• Deliver pharmacovigilance training to local employees and stakeholders.
• Maintain local PV product lists, records, and archives.
• Support vigilance requirements for medicinal products, medical devices, and food supplements.
• Coordinate and support pharmacovigilance audits, inspections, and compliance activities.
• Manage local PV agreements with distributors, partners, and service providers.
• Collaborate with internal and external stakeholders to ensure effective safety reporting and compliance.
• Support regional and global pharmacovigilance projects as required.

Required profile

• Highly motivated professional.

Required skills