Senior Clinical Safety Scientist
vor 3 Wochen
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.
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