Associate Director, Clinical Safety in Basking Ridge, NJ at DSI

Date Posted: 6/6/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    6/6/2020
  • Job ID:
    10324BR

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

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/Experience:

MD degree with board eligibility
1 year of clinical experience desirable

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.