Affiliate Safety Representative

The Affiliate Safety Representative (ASR) is responsible for ensuring that all aspects of Pharmacovigilance (PV) within the Affiliate meet AbbVie’s statutory and ethical standards, and comply with local and regional PV regulations for the product portfolio. The ASR acts as the Affiliate’s Lead for PV matters with the National Regulatory Agency and AbbVie Global Patient Safety (GPS) PSEQ function.

Key Responsibilities:

• Oversight of the local Pharmacovigilance System to ensure compliance with AbbVie Global procedures and relevant regulations.
• Collaborate with Regional PV Teams and partners to monitor PV activities and performance.
• Partner to maintain Quality Management Systems and oversee PV training compliance.
• Ensure robust systems for Adverse Event and Periodic Safety Reporting across spontaneous, solicited, and clinical study sources.
• Serve as Affiliate lead during Regulatory Authority PV in...