Director, Clinical Safety Risk Management (Clinical Safety & Pharmacovigilance)

Job Description

Join a Legacy of Innovation 110 Years and Counting!

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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.

Summary

The Clinical Safety Risk Management Director is responsible for providing strategic advice and support to global project teams (GPTs) on issues related to RMPs and REMS. This individual will also be the RM champion in the organization and oversee high-profile global projects or RM initiatives, such as safety knowledge groups and establishing enhanced global oversight of RM activities at the affiliate level. This individual will perform all key responsibilities with minimum supervision.

Responsibilities

• Strategic Advice and Support to GPTs: 1) Provides expert, strategic advice on the creation and submission of RMPs and REMS. 2) Own and maintains the process for creating core RMPs. 3) Provides expert, strategic advice on executing the requirements of RMP/REMS (including acquiring appropriate tools and competent vendors). 4) With project management support, guides and supports teams on tracking submissions (and following the status of submissions). 5) Guides in creating assessment reports. 6) Guides and supports with the alignment of RMPs, labels in key regions (US, EU, Japan) and periodic reports.
• Global Risk Management Champion: Spearheads the enhancement of global RM oversight at the affiliate level. Serves as the internal expert on RM and maintains knowledge of regulator and industry trends related to RM. May draft and/or propose changes to SOPs/SOIs related to RM. Keeps management aware of any gaps in RM planning, creation and execution.
• Project Management: With the support of a RM project manager or associate director, oversees the project management of key RM initiatives as defined by leadership.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)

• Bachelor's Degree required
• Master's Degree preferred
• PharmD preferred
• PhD preferred
• RNs may be considered

Experience Qualifications

• 6+ years of relevant experience required

Travel

Ability to travel up to 20%

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.