Senior Clinical Safety Scientist

hace 7 meses


All, España Daiichi Sankyo Europe A tiempo completo

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 European Headqurters in Munich we are looking for a 

Senior Clinical Safety Scientist (m/f/x) 

The position:

The Senior Manager, Clinical Safety Scientist Oncology supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle and independently leads activities without supervision for assigned clinical studies. 

The job holder acts as Subject matter expert (SME) in one or more focus areas and may start to develop people management skills by mentoring and coaching junior Clinical Safety Scientists or post-doctoral fellows. 

The job holder acts as audit/inspection SME for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation, and may serve as primary or back-up SME.

Roles & responsibilities.

Risk Management (Signal identification, evaluation, mitigation):

Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle

Independently evaluates safety data of any source to identify potential safety signals, tracks safety signals in the global electronic signal tracking tool and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teams

Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetings

Collaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs)

Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product

Safety Communication:

Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents

Collaborates with Clinical Safety Scientist Lead and PSL to author safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)

Contributes to regulatory authority requests or communication for assigned clinical studies

CTD submissions/Others:

May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of CTD

Develop expertise in one or more focus areas

Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed

Acts as audit/inspection Subject Matter Expert (SME) for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation, serving as primary or back-up SME

Project Management:

Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the Clinical Safety Scientist Product Lead and PSL

May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed

Professional experience & education:

Education and experience

Bachelor’s degree at minimum required; PharmD or PhD preferred 

2 years of experience with an advanced degree; 5 years of experience with a bachelor’s degree 

Possesses scientific or therapeutic area, and drug development knowledge

Experience in summarizing and presenting safety data

Experience in project management and working in a matrix environment

International, European and PV laws

Fluent business English (oral and written) 

Competencies and generic skills

High reliability and accuracy

Analytic and systematic approach

Ability to understand complex matters 

Strong communication skills

Good problem-solving skills, respect and appreciation for cultural diversity

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.



  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Senior Manager, Clinical ScientistDaiichi Sankyo Europe seeks a Senior Manager, Clinical Scientist to oversee clinical trials and develop regulatory documents. As a key member of the clinical development team, this individual will provide medical and scientific direction to Clinical Operations and represent the company on Project Teams.


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    OverviewDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that enrich the quality of life.Estimated Salary€80,000 - €110,000 per year based on experience and qualifications.Job DescriptionSenior Safety Scientist (m/f/x)This role requires a highly qualified candidate to...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Overview:">Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments for patients worldwide.We are seeking a highly skilled Senior Safety Scientist to join our team in Munich, Germany, and contribute to the post-marketing surveillance of our oncology products.Job Description:The...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    We are seeking a highly experienced Lead Product Safety Director to join our team at Daiichi Sankyo Europe. In this role, you will be responsible for leading product safety strategies and providing safety leadership in clinical studies, post-marketing surveillance, signal detection, and risk management.ResponsibilitiesDevelop and implement overall product...

  • Safety Physician

    hace 6 meses


    All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    About Daiichi Sankyo EuropeWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that enrich the quality of life for patients around the world.Job OverviewWe are seeking an experienced Safety Physician to join our team as Director ADC in Munich, Germany. The successful candidate will be responsible...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    OverviewDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative solutions for patients worldwide.Job DescriptionWe are seeking an experienced Data Scientist AI/ML Innovation Lead to join our team in Munich, Germany. The successful candidate will be responsible for managing end-to-end delivery...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Job DescriptionWe are seeking a highly qualified Data Scientist to join our team in Munich, Germany. This role will be responsible for managing end-to-end delivery of AI/ML projects, partnering with internal and external stakeholders, and optimizing AI/ML technology and processes.About the RoleThe position holder will have a strong knowledge of AI/ML...

  • Global Oncology HEOR

    hace 6 meses


    All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    About Daiichi Sankyo EuropeWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments for patients worldwide. With over 120 years of experience and more than 17,000 employees across 20 countries, we strive to make a meaningful difference in the lives of those affected by cardiovascular disease.


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Daiichi Sankyo Europe is seeking a highly qualified Medical Director for Cardiovascular Therapies to join our team.About UsWith 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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Job Description:Daiichi Sankyo Europe is seeking a highly skilled Senior Manager Statistical Programming Expert to provide technical support to project teams on statistical programming deliverables and submissions.Responsibilities:Support project lead on outsourced projects, acting as a statistical programming subject matter expert (SME) to ensure correct...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...