Senior Director Safety Physician Specialty Medicines - Munich, Deutschland - Daiichi Sankyo Europe GmbH

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    Beschreibung

    With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

    In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

    Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

    For our headquarter in Munich or other affiliates in Europe we are seeking highly qualified candidates to fill the position

    Senior Director Safety Physician Specialty Medicines (m/f/x)

    The position:
    Provides expertise in medical safety activities for the assigned projects / products including development of safety monitoring plan, effective implementation of safety monitoring activities, Benefit/Risk assessment with appropriate risk minimization activities, and effectively communicates with internal and external stakeholders, within the framework of safety management team (SMT). The incumbent provides strong leadership to successfully coordinate resources, ensures effective collaboration, and ensures delivery of all essential activities across the life cycle of the assigned products, either directly or via mentoring / management of junior physicians or scientists. Essential clinical safety activities for marketed and development products include but not limited to the following: (such as signal detection activities, chairing of SMT, signal assessment reports, review of study protocols, ICF, IB, CSR, submission activities for new indications / line extensions, response to HA requests, aggregate reports, RMPs, label changes, and deliver on post approval commitments)
    This position will also contribute to the Centers of Excellence activities (e.g. Risk Management, Signal Detection, and medical review of ICSRs).

    Reporting:
    Reports to the European Senior Director Oncology Value, Access & Pricing

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