Affiliate Safety Representative - North

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

In collaboration with the AMD and MENA Regional PV lead (RPL), Lead the coordination and execution of all aspects of pharmacovigilance (PV) at the affiliate level to ensure that Abb Vie’s statutory and ethical responsibilities are met.

Acts as the Affiliate’s main contact point for pharmacovigilance matters with the National Regulatory Agency and Abb Vie Global Patient Safety (GPS) function.

Serves as the National Qualified Person for Pharmacovigilance (NQPPV) when applicable, with sufficient authority to influence the performance of the quality system and pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements. Detailed role profile outlining the specific accountabilities of the role are described in the country attestation form.

Provides strategic leadership to manage and support the PV team in executing assigned responsibilities.

Supports recruitment, on-boarding, training, development through coach and mentoring, performance management, and succession planning of appropriately skilled PV staff

• Ensures that PV processes, procedures and systems are in place to comply with Abb Vie Global PV procedures and with local and/or regional PV regulations.
• Maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by the Regional PV Teams and/or outsourced partners, in collaboration with Regional PV Leaders who oversee day-to-day operational PV activities
• Maintains oversight of Abb Vie’s PV system master file (PSMF) with the authority to ensure that the information contained is an accurate and up-to-date reflection of the PV system.
• Delegates specific tasks under supervision and with documentation, to appropriately qualified and trained individuals, provided that the QPPV maintains system oversight and overview of the safety profiles of all products.

Partners with the Regional PV Teams to:

• Ensure Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
• Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
• Maintain oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with Corporate and Local PV training requirements.
• Oversee training compliance of partner company staff according to local contract requirements.

• Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, follow up, translating and reconciling adverse events and other safety information reportable to GPS from spontaneous and solicited sources and from clinical studies.
• Partners with the Regional PV Teams in GPS to ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agencies, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.

• Serves as the affiliate Lead and point of contact for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall Abb Vie PV system and how Global PV processes and GPS Regional PV Teams are set-up and…