Pharmaceutical Scientist - Product Safety, Risk Management (m/f/d)

Daiichi Sankyo Europe GmbH

Berufsfeld
Technik

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Pharmaceutical Scientist - Product Safety, Risk Management (m/f/d), Daiichi Sankyo Europe GmbH

Passion for Innovation. Compassion for Patients. 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 headquarters in Munich we are seeking highly qualified candidates to fill the position: Senior Safety Scientist (m/f/x) The position: As a safety scientist you will provide scientific expertise and support proactive safety surveillance and risk management activities in conjunction with the Product Safety Lead Physician for Quizartinib and cross-functional team(s) in support of benefit risk profile during post-marketing phase. Support Quizartinib product maintenance during post marketing including: Support of post marketing risk management activities (RMP, aRMM) Support generation of periodic reports (PSUR, Regional aggregate reports) and responses to health authority requests Collaborate with Product Safety Lead for set-up and analysis of Post-marketing studies/registries Review of scientific literature Support of the PSMF generation for product related information Risk management and Safety communication: Support for implementation of strategy for risk minimization Support of product safety physician for signal detection Development of strategy for communication of safety information Development of safety communication documents and aggregate safety reports Responsible for Signal Tracking and Deviation Management with safety related activities (e.g. RMP) Bachelor's degree at minimum required; PharmD or PhD preferred Professional experience of at least 5 - 7 years in a similar position within the pharmaceutical industry Experience in summarizing and presenting safety data Possesses strong clinical safety & PV knowledge Experience in project management and working in a global matrix environment Experience in International, European and Pharmacovigilance laws Oncology product experience is preferred Fluent English in written and spoken We are looking for a flexible, stress-resistant team player who can work reliably also under time pressure. Your thinking is analytical and structured; your work style shows a high level of responsibility and quality consciousness. If you in addition like to work in a multi-cultural and international cooperation, then you are the right person for us. Competitive Pay Work-Life Balance Growth and Development Health and Family

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