Company Description
About AbbVie
AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Support the Affiliate Safety Representative (ASR) and the North LATAM Cluster pharmacovigilance system by executing, coordinating and monitoring pharmacovigilance activities in compliance with AbbVie procedures, applicable local regulatory requirements and established quality standards. Serve as a functional liaison among internal teams, vendors and business partners to ensure effective implementation of pharmacovigilance processes across assigned countries. When formally designated,
act as ASR Backup for specified countries or activities in accordance with documented delegations and applicable requirements, while the ASR retains final oversight and accountability.
1. Pharmacovigilance operations and regulatory reporting
Support the maintenance and implementation of local pharmacovigilance processes, procedures, systems and documentation. Oversee the receipt, processing, follow-up, reconciliation and reporting of adverse events and other safety information; monitor applicable timelines for ICSRs and other regulatory reports; and support aggregate reports, PSURs/PBRERs, RMPs and local requirements, as applicable.
2. Quality system, compliance, audits and inspections
Support the pharmacovigilance quality system across North LATAM Cluster countries. Coordinate follow-up of deviations, observations, CAPAs, change controls and exceptions; maintain training and compliance records; participate in regulatory inspections and inte