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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. Job Description: Lead the coordination and execution of all aspects of pharmacovigilance at the affiliate to ensure that AbbVie's statutory and ethical responsibilities are met. Act as the Affiliate's back-up contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety (PPS) function. Provide strategic leadership to manage and support the Pharmacovigilance (PV) team in executing assigned responsibilities. Serve as the local Qualified Person for Pharmacovigilance (QPPV) back-up in Colombia 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. Responsibilities: - Leadership and management - Build and maintain effective business relationships across the affiliate to support the implementation of patient safety standards. - Maintain an environment of continuous improvement to optimize the affiliate PV system and contribute to regional and global process improvement initiatives working with PPS subject matter experts. - Communicate effectively to achieve affiliate/regional/area cross-functional alignment and engagement for a better understanding of the PV strategies and processes to leverage it for success. - Oversight of the Pharmacovigilance System - Maintain oversight of affiliate PV compliance status and actively monitor PV workload and resources. - Escalate compliance issues and potential PV resource issues in a timely manner to the Affiliate Medical Director and International PV Operational Excellence (IPEx) to ensure appropriate mitigation. - Maintain awareness and monitor local post-marketing and clinical PV legislation to ensure PV legislation changes are communicated to relevant stakeholders for review impact assessment implementation and mitigation according to global procedures. - Has access to AbbVie'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 in Colombia. - Quality Management System - Ensure the 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. - Adverse Event & Periodic Safety Reporting - Ensure that processes procedures and systems are in place for intake processing conducting follow up translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies. - Ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency Ethics Committees and Investigators to comply with corporate PV procedures and with local and regional PV regulations as required. - Audits and Inspections - Act as the key Affiliate back-up for both internal PV audits and Regulatory Agency PV inspections. - Ensure that any audit/inspection responses/corrective actions are completed according to the schedule. - Support local QA and R&D; PV QA to conduct vendor audits and complete vendor corrective action plans. - Risk Management - As a member of the Affiliate Risk Management Team (ARMT) review Risk Management Plans (RMPs) and implement risk minimization measures at the affiliate according to AbbVie procedures and local requirements. - Understand the RMPs and information on the benefit/risk profile of products applicable for the Affiliate. - Ensure the appropriate development and revision of Local RMPs and/or Country Specific Annexes if applicable liaising with ARMT & Benefit Risk Management (BRM) Team during development and revision of local documents. - Partner with ARMT & Benefit Risk Management (BRM) Team during development or revision of the Local Implementation Plan (LIP) & local additional risk minimization measures. - Safety Monitoring - Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction and awareness of conditions or obligations adopted as part of the marketing authorizations commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency. - Understand and monitor incoming local safety data and communicate changes or potential concerns to the PPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation. - Ensure a full and prompt response to regulatory agency requests for provision of additional information necessary for the benefit-risk evaluation of a medicinal product. - As back-up delegate 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 in Colombia. - After Hours Availability & Business Continuity - Ensure availability to be at AbbVie's disposal permanently and continuously on a 24-hour basis in Colombia. - Ensure that an after-hours process is in place for the reporting of AEs. - Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV. - INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS: - Affiliate medical regulatory affairs clinical quality assurance and customer service personnel. - Affiliate Marketing Sales and Operations personnel to ensure that all employees are trained and understand their responsibilities for reporting of any safety information. - National Regulatory Agency responsible for product safety. - Pharmacovigilance and Patient Safety including but not limited to IPEx Area PV Product Lead Benefit-Risk Management and QPPV Office. - Healthcare Practitioners consumers and patients.