Global Good pharmacovigilance practices (GVP) Auditor (f/m/d)

Global Good pharmacovigilance practices (GVP) Auditor (f/m/d) About ITM ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM). We would like to fill the following vacancy as soon as possible: Global GVP Auditor (f/m/d) Your Role: Implementation, management and oversight of the ITM GVP audit schedule Lead the development and implementation of the PV audit strategy in alignment with the QPPV and R&D organization Responsibility for the execution of the PV audit schedule Ensure the conduct of GVP external vendor, commercial partner, and internal process/system audits according to internal and external GVP requirements Review and approve audit responses and evaluate adequacy of corrective and/or preventative action plans in collaboration with the QPPV Office and PV Operations teams Provide GVP Compliance SME support during global regulatory agency inspections and other audits of IT offices What we are looking for: Bachelor’s Degree in a science related field or comparable education More than eight years of relevant pharmaceutical industry experience, ideally more than five years of direct Pharmacovigilance / GVP experience Auditor certification or auditor exam completion obtained Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside GVP Compliance, including senior management, regulatory agency personnel, vendor personnel, contracted service providers and consultants Excellent English (oral and written) Working knowledge of global GVP, GCP, quality risk management as well as computerized system validation regulations and guidelines and international regulatory practices Good eye for detail and commitment to seeing tasks through to completion Ability to write comprehensive audit reports and summary documentation for senior management and functional areas responsible for supporting Proven organizational skills and strong ability to prioritize workload Willingness to conduct audits globally in-person and remotely What we offer: A modern workplace and exciting opportunities in an evolving and fast growing company Challenging and varied projects in interdisciplinary, multicultural and highly professional teams A collegial corporate culture and short communication channels Flexible working hours with an attractive salary package and diverse corporate benefits At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion – the input of our multi-cultural employees makes us who we are. Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”. Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment? Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Isotope Technologies Munich SE, a company of the ITM group. Applications are accepted either in German or English language. Contact for your application: ITM Isotope Technologies Munich SE Human Resources Walther-von-Dyck-Straße 4 85748 Garching / Munich, Germany E-Mail: career@itm-radiopharma.com Phone: +49 089 329 8986 1706 Contact: Elisabeth von der Grün For more information please visit: www.itm-radiopharma.com