وظائف مهندس تفتيش هندسي - تونس العاصمة تونس

<p>JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people s health. We re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works at Tunusia location in the Established Pharmaceuticals Division that we are committed to bringing the benefits of our trusted medicines to more people in the world s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. What You'll Do The Affiliate Safety Representative (ASR) in French Africa Cluster (FAC) and ASR back-up during absence of the main ASR in English Africa Cluster (EAC) Affiliate ensures that all activities related to pharmacovigilance (PV) for both Abbott EPD investigational and registered medicinal products are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirements. The ASR further is the primary pharmacovigilance interface of Abbott EPD with local health authorities and represents pharmacovigilance internally within the Affiliate organization. Core Job Responsibilities: Acts as a local QPPV on a 24/7/365 basis in FAC Affiliate. Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance Receipt, recording, and reconciliation of safety information Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans Regulatory submission of safety information Basic PV training of local EPD staff PV record retention and archiving Implementation of out-of-office coverage for receiving and recording safety-relevant information Maintenance of local PV product list Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization Provision of local PV Compliance metrics and management of non-compliances Coordination/management of PV audits and inspections at the Affiliate leve Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements The role takes responsibility for implementation and maintenance of a functional and compliant local PV system: Implementation of local legislative and Abbott internal requirements in FAC Affiliates Local PV interface to Health Authorities PV point of contact for Affiliate non-PV functions and GPV headquarter Works in collaboration with local non-PV stakeholders to maintain a timely and complete exchange of PV-relevant information Supports the Manager PV Regional or GPV headquarter for specific global projects, as assigned Deputizes for Manager PV Regional during absence In additional as an ASR BU role takes responsibility for maintaining a functional and compliant PV system in EAC Affiliate.&nbsp;</p><p><strong>Desired Candidate Profile</strong></p><p>Ideally graduate with a Life Sciences or Pharmacy degree or equivalent qualification PV experience in pharmaceutical company is preferred Understanding of local PV regulation Ability to give attention to the detail Computer literacy (Windows, MS Office) Good English language skills Good communication skills with internal and external stakeholders</p>