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29/06/2022 | Berufe

Der optimale Berufseinstieg: Mittelstand

Der optimale Berufseinstieg: Mittelstand

Noch immer wünschen sich viele AbsolventInnen einen gut bezahlten Job in einem großen Unternehmen mit starker Marke. Warum KMU-Arbeitgeber aus unserer Sicht jedoch die optimale Wahl für den Berufseinstieg sind, erläutern wir hier.

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Global Pharmacovigilance Operations Expert (f/m/d)

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Global Pharmacovigilance Operations Expert (f/m/d) im Unternehmen "ITM Oncologics GmbH" in Garching bei München - 27.04.2022

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Responsible for partner and vendor management in relation to Pharmacovigilance, to ensure adherence and compliance with applicable SMPs, KPIs / Metrics, PVAs and other contractual agreements. Escalate issues when necessary; ensure stringent;...

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ITM Oncologics GmbH (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 Pharmacovigilance Operations Expert (f/m/d) Your Role: Responsible for partner and vendor management in relation to Pharmacovigilance, to ensure adherence and compliance with applicable SMPs, KPIs / Metrics, PVAs and other contractual agreements. Escalate issues when necessary Ensure stringent and timely exchange of PV-related data with partners according to contracts / PVAs / SDEAs / trial specific plans Ensure that individual ICSRs are reported in compliance with ITM procedures, regulations and contracts Support the maintenance and expansion of an international pharmacovigilance system including the develop and maintain standard operating procedures and working instructions for the global drug safety and pharmacovigilance department Track changes in legal and regulatory requirements in the area of drug safety and pharmacovigilance (Pharmacovigilance Intelligence) Assist with the inspection readiness process for pharmacovigilance, audit/inspection responses from PV and vendor Participate in development of PV specific metrics and KPIs e.g. for partner and vendor management, follow-up on their compliance and ensure proper documentation Support the preparation of PV contractual agreements with service providers, partners and subsidiaries Interact regularly with other internal departments globally and locally, such as Clinical Operations, Quality Affairs and Regulatory Affairs Maintain good documentation practice for all safety operation documents Support pharmacovigilance leadership in assigned activities and actively participate in daily pharmacovigilance activities with a can-do, hands-on, positive attitude What we are looking for: University degree with a focus on the natural sciences, human medicine or pharmacy Professional experience in the pharmaceutical industry, with ideally at least three years of experience within drug safety and pharmacovigilance Knowledge of regulatory requirements pertaining to GVP, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally Experience in safety (quality) systems and tracking metrics, compliance monitoring Ability to work in a team and solution-oriented Independent and structured way of working, attention to detail and accuracy Very good knowledge of English, both written and spoken; German language skills are a plus Good computer skills (Word, Excel, PowerPoint, Outlook email) and familiarity with safety systems 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, diverse corporate benefits and home office possibilities 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 Oncologics GmbH, 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-Str. 4 85748 Garching / Munich, Germany E-Mail: Phone: +49 089 329 8986 1705 For more information please visit: