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Global Patient Safety (GPS) Risk Management Leader (gn)
Planegg
Aktualität: 31.07.2021

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31.07.2021, MorphoSys AG
Planegg
Global Patient Safety (GPS) Risk Management Leader (gn)
Deliver effective safety and risk-management expertise for safety-based decision-making and benefit-risk assessments across the life cycles of MorphoSys products Lead the GPS Risk Management Group, planning, managing and ensuring delivery of all GPS risk-management activities, with adequate resourcing and patient safety capabilities Establish effective working relationships cross-functionally and with business partners and vendors Represent GPS internally, and MorphoSys externally, to advance safety and risk management decision-making and methodology
Clinical experience in a hospital or community-based healthcare environment Strong medical / scientific knowledge in general, and ideally in hemato-oncology, and/or autoimmune disorders Extensive industry experience as a pharmaceutical physician in clinical safety and risk management on a global / corporate level, including both post-marketing pharmacovigilance and clinical development (including medical safety evaluation, signal and risk management activities, and benefit-risk evaluation; and regulatory submissions for marketing licence applications in the EU and/or the USA, including for biologic products); whilst there is no absolute length of such experience required, as a guide this would typically require at least ten years Extensive and broad understanding of the pharmaceutical industry, including trends and future developments in pharmacovigilance, and pharmacovigilance legislation including ICH-GCP and clinical safety guidelines, EU Clinical Trials Directive and EMA GVP Modules, and FDA clinical safety and risk management guidance Experience in building and leading successful teams Recognised external profile in pharmacovigilance, therapeutic or clinical development networks (e.g. speaker at professional conferences and workshops, representation on external policy-making or educational groups) Strong leadership skills, able to command respect and authority, and influence decision-making Strategic thinking Project management skills, ability to plan and prioritise work within teams adapting to rapidly changing priorities managing multiple situations / issues under time pressure Ability to remain calm under pressure, maintaining clear thinking and communication Proven change management expertise Strong communication skills, oral and written - ability to present information clearly and concisely Strong team-working skills (developed from practical experience of global working) Skills in people management, including building teams, driving performance and developing individuals Excellent problem-solving and decision-making ability Fluent spoken and written professional English essential; written and spoken German an advantage

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