Associate Director, Clinical Safety Risk Management

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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, as well as other research areas centered around rare diseases and immune disorders.

Job Summary

Position will be a member of the Risk Management Center of Excellence office who will help manage risk management initiatives and activities defined by leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management tools and resources.

Responsibilities

Job Description

Strategic Advice And Support To Global Product Teams

• Provides expert, strategic advice on the creation and submission of RMPs and REMS.
• Own and maintain the process for creating RMPs.
• Provides expert, strategic advice on executing the requirements of RMP/REMS (including acquiring appropriate tools and competent vendors).
• Guides and supports teams on tracking submissions (and following the status of submissions).
• Guides in creating assessment reports.
• Guides and supports with the alignment of RMPs, labels in key regions (US, EU, Japan) and periodic reports.
  
  

Risk Management Champion

• Serves as member of the Risk Management office to provide knowledge of regulator and industry trends related to risk management.
• May draft and/or propose changes to SOPs/SOIs related to risk management.
• Keeps management aware of any gaps in risk management planning, creation, and execution Lead/Manage RMP initiatives.
• Lead and/manage RMP initiatives and activities related to risk management planning, risk management sciences, and risk management tools and resources.
• Risk Management Compliance & Inspection Readiness Champion.
• Serve as member of Risk Management office to ensure risk management activities allow for effective preparation for inspections/audits.
• Serve a key support during Risk Management Inspections.
  
  

Qualifications

Education Qualifications

• Bachelor's degree in healthcare related field required
• PharmD or PhD preferred
  
  

Experience Qualifications

• 4 or more years of relevant experience in risk management and project management required
  
  

Travel Requirements

• Ability to travel up to 20% of the time. Domestic and International travel.
  
  

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$150,800.00 - USD$226,200.00