Position independently handles aspects of signal identification, evaluation, and risk mitigation across therapeutic areas. This position proactively creates communication plans for important safety topics and identified risks. Additionally, this position may serve as primary author for certain safety documents and regulatory submissions and reviews protocols and ICFs. Additionally, this position project manages larger Phase 3 or 4 SMTs and supervises junior scientist project managing smaller SMTs. This position works closely with CSPV staff, SMT members, and occasionally IPT members and other functions. Finally, this position works on the most complex problems and makes decisions regarding project management work within CSPV.
Risk Management (Signal identification, evaluation, mitigation): Is a key participant in developing, and possibly implementing, the risk management strategy for assigned products/ TAs. Demonstrates familiarity with PV/Epi related literature. Assists CS physician in assessing new signals. May independently integrate and analyze safety data from multiple sources to deliver comprehensive conclusions.
Safety Communication: Develops strategy for communicating safety information internally and externally with CS physician. May first author safety communications.
Documentation: Documents meeting discussions, decisions, action items, and SMT activities independently. Ensures the appropriate archiving of the team meeting documentation and SMT activities independently. Maintains a current signal tracking log independently.
Project Management: Serves as PM for SMTs devoted to larger Phase 3/4 products and ensures adherence to project timeline. Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. Coaches, mentors, and influences junior scientists and team members.
Education and Experience
- Possesses strong medical or TA and drug development knowledge
- 3 years of experience with an advanced degree; 5 years of experience with a Bachelor's degree
- Bachelor's degree at minimum required; PharmD or PhD preferred
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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