Associate Director, Clinical Safety MD

1 month ago

Basking Ridge, United States Daiichi Sankyo Full time

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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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.

Summary

This position supports safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities.

Responsibilities

* Safety Expert - Overall: Develops safety knowledge working closely with CSPV management.
* Safety Expert - Signal Identification: Carries out routine signal identification activities formulated by manager. Uses medical knowledge to aid the SMT's signal identification efforts.
* Safety Expert - Signal Evaluation: Assists manager in assessing new signals.
* Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members.
* Reports and Submissions: May contribute to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy.

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)

* MD with board eligibility preferred

Experience Qualifications

* 1 or More Years of clinical experience preferred

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.

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