Senior Manager Clinical Safety Scientist (m/f/x)

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Datum: 19.07.2021

Standort: München, Deutschland, 8

Unternehmen: Daiichi Sankyo Europe

Gesellschaft: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For more information: www.daiichi-sankyo.eu.

For our headquarter in Munich we are seeking highly qualified candidates to fill the position of

Senior Manager Clinical Safety Scientist (m/f/x)

 

The position:

 

The Senior Manager, Clinical Safety Scientist, will handle aspects of signal identification, evaluation, and risk mitigation across therapeutic areas, in collaboration with product safety leads.  This position proactively creates communication plans for important safety topics and identified risks.  This position may serve as primary author for certain safety documents and regulatory submissions (NDA/BLA in US and MAA in EU).  Additionally, this position project manages larger Phase 3 Studies, Safety Management Team (SMT) meetings and supervises junior scientist to work together as a team.  This position works closely with CSPV staff, SMT members and other functions.

 

Roles and responsibilities:

 

Oncology Product Risk Management support for pivotal clinical studies and BLA/MAA activities

  • A key participant in developing and implementing the risk management strategy for assigned oncology products
  • Works with Product Safety Physician for pivotal clinical study maintenance
  • Works with Product Safety Physician to support regulatory submissions (NDA/BLA in US and MAA in EU) and develops the strategy for risk minimization activities for post-marketing

Risk Management (Signal identification, evaluation, mitigation) and Safety Communication

  • Support Product Safety Physician for signal discussion at Safety Management Team (SMT)
  • Independently integrates and analyses safety data from multiple sources to deliver comprehensive conclusions
  • Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately
  • Develops strategy for communicating safety information internally and externally in collaboration with product safety lead
  • Leads the development of safety communication documents and aggregate safety reports

Project Management

  • Serves as Project Management for Signal Management and Safety Management Team devoted to larger Phase 3 products and ensures adherence to project timeline
  • Responsible for Signal Tracking and Deviation Management with safety related activities (e.g. RMP)

 

Personal skills and professional experience:

 

  • Bachelor’s degree at minimum required; PharmD or PhD preferred 
  • 5 years of experience with an advanced degree; 7 years of experience with a bachelor’s degree
  • Possesses strong medical and drug development knowledge 
  • Experience in summarizing and presenting safety data
  • Experience in NDA/BLA and/or MAA submission activity
  • Strong communication skills
  • Experience in project management and working in a matrix environment
  • International, European and PV laws
  • Fluent business English (oral and written)

 

What we offer: 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

 

Please apply online at our Career Portal. We are looking foward to hearing from you.