Associate Director, Clinical Safety Risk Management

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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.

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.

Education Qualifications

• Bachelor's degree in healthcare related field required
• Pharm
  
  D 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$ - USD$