Affiliate Safety Representative; ASR

Company Description

About Abb Vie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Ready to make an impact on patient safety? Abb Vie is seeking a leader to drive Pharmacovigilance at the affiliate level, reporting to our Medical Director, ensuring our product portfolio meets the highest standards of safety and regulatory compliance. As the key interface between our affiliate, national regulatory agencies, and our Global Patient Safety function, you’ll shape quality systems and champion best practices.

In this pivotal role, you’ll independently drive local pharmacovigilance activities as a key individual contributor, ensuring operational excellence and compliance, while also managing one direct report. If you’re looking to play a key role across our innovative therapeutics and leave no eligible patient behind, this opportunity is for you.

Oversight of the Pharmacovigilance System

• 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 fulfill local and applicable regional PV regulations, including those performed by the Regional PV Team and/or outsourced partners and has access to the Abb Vie’s PV System Master File (PSMF).
• Acts as key safety advisor for affiliate cross‑functional partners on safety topics

Quality Management System

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.

Adverse Event & Periodic Safety Reporting

• Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, follow up, translation and reconciliation of adverse events and other safety information reportable to GPS from spontaneous and solicited sources as well as from clinical studies.
• Partners with the Regional PV Team 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, in compliance with corporate PV procedures and with local and regional PV regulations as required.

Launch Readiness

• Sets a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product or indication launch at the affiliate.
• Acts as key safety advisor for affiliate cross‑functional partners on safety topics.

Legislation Intelligence

• Collaborates with the GPS Regional PV Teams to ensure monitoring of local (and applicable regional/area) PV‑relevant hard intelligence, and leads the impact assessment of such intelligence.

Audits and Inspections

• 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 the GPS Regional PV Teams are set‑up and structured, supporting the fulfillment of local legal requirements.

PV Business partnering

• Acts as key safety advisor for affiliate cross‑functional partners on safety topics ensuring that…