Director, Medical Reviewer - Clinical Safety

Location
Basking Ridge, NJ, United States
Posted
Nov 13, 2020
Ref
10552BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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. 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:

The Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds and marketed products. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role will interact with other key roles, collaborating with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development/lifecycle of DSI products (i.e., Phase I through commercialization).

Responsibilities:

Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians responsible for a compound/product including project management, project-specific training and coaching of team members, review of team output cross-functionally.

Provides oversight of expert medical review, assessment and communication of ICSRs in both the investigational and marketed settings. Ensures ICSR reporting meets all relevant internal timelines. Provides oversight and/or performs all key responsibilities with minimum supervision.

Ultimately decides if an adverse event is an expeditable report. Maintains knowledge and follows regulatory guidance, protocol requirements and department processes for proper ICSR handling. From a medical perspective, ensures that ICSRs are reported within all relevant internal timelines. Anticipates problems with compliance and creates solutions in a timely manner.

Review and analyze data from clinical trials for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical trials for completeness, accuracy, expectedness and relatedness.

Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.

Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.

Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables (to agreed timelines).

Provides medical review and assessment of ICSRs, including evaluation of the case narrative for accuracy, medical logic and completeness and review of coding and expectedness (against relevant reference documents). Uses medical knowledge, product knowledge and experience to determine potential causes of reported adverse events. Determines or confirms the company causality and authors or oversees the causality statement. As requested by management, participates in safety meetings to enhance medical assessment of adverse events of special interest or complex adverse events.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

MD, Board certification or eligibility

At least 3-5 years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology

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.

Job Title
Director, Medical Reviewer - Clinical Safety

City
Basking Ridge

Functional Area
CSPV

State
New Jersey