Senior Clinical Safety Scientist

Senior Clinical Safety Scientist

Daiichi Sankyo Europe

Multiple Locations, Europe

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

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