About the job
JOB SUMMARY:
In partnership with the AMD and MENA Regional PV lead (RPL), spearhead the coordination and implementation of all pharmacovigilance (PV) activities at the affiliate level, ensuring compliance with AbbVie’s legal and ethical obligations.
Serve as the primary liaison for pharmacovigilance matters with the National Regulatory Agency and the AbbVie Global Patient Safety (GPS) team.
Function as the National Qualified Person for Pharmacovigilance (NQPPV) when applicable, possessing the authority to influence the quality system's performance and pharmacovigilance activities while enhancing compliance with legal mandates. A detailed role profile outlining specific accountabilities is available in the country attestation form.
Provide strategic leadership to the PV team, managing and supporting them in executing their responsibilities effectively.
Assist in the recruitment, onboarding, training, and development of skilled PV personnel through coaching, mentoring, performance management, and succession planning.
KEY DUTIES AND RESPONSIBILITIES:
Oversight of the Pharmacovigilance System
- Ensure that PV processes, procedures, and systems are established to adhere to AbbVie Global PV standards and local/regional regulations.
- Oversee the performance of all activities that comply with local and applicable regional PV regulations, including those executed by Regional PV Teams and/or outsourced partners, in collaboration with Regional PV Leaders.
- Maintain authority over AbbVie’s PV system master file (PSMF), ensuring it accurately reflects the current state of the PV system.
- Delegate specific tasks under supervision to qualified and trained individuals while ensuring the QPPV maintains overall system oversight and product safety profiles.
Quality Management System
Collaborate with Regional PV Teams to:
- Ensure Affiliate PV System procedures align with corporate PV guidelines and comply with local and regional regulations.
- Address any non-conformities and planned deviations from corporate and local PV procedures according to the global issue management process, ensuring timely completion of corrective actions.
- Oversee the PV training plan and ensure compliance among local PV staff and affiliate personnel with corporate and local training requirements.
- Ensure training compliance of partner company personnel as per local contract stipulations.

