Job Summary We are seeking a skilled Pharmacovigilance professional to lead the coordination and execution of all aspects of pharmacovigilance at our affiliate. The successful candidate will be responsible for ensuring that our statutory and ethical responsibilities are met, as well as providing strategic leadership to manage and support the Pharmacovigilance team in executing assigned responsibilities. This role is ideal for a detail-oriented individual with strong analytical skills and excellent communication abilities. If you have a passion for pharmacovigilance and are looking for a challenging role, please apply. Key Responsibilities: - Leadership and Management - B - 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. - C - 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. - Awareness and monitoring of 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. - Access to AbbVie's PV system master file (PSMF) with 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 - 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. - 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.