Director, Clinical Safety Scientist

Job Summary

Responsibilities

Risk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately.

Safety Communication: Develops strategy for communicating safety information internally and externally in collaboration with product safety lead. Leads the development of safety communication documents and aggregate safety reports.

Project Management: Serves as PM for SMTs devoted to larger Phase 3/4 products and ensures adherence to project timeline.

People Management and Mentoring: Coaches, mentors, and influences junior scientists and team members.

Qualifications

Education Qualifications
Bachelor's Degree required; PhD preferred or PharmD preferred

Experience Qualifications
7 or More Years of experience with an advanced degree required
10 or More Years of experience with a bachelor’s degree preferred
Experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required 
Possesses strong medical and drug development knowledge required 
Experience in summarizing and presenting safety data required 
Strong communication skills required 
Experience in project management and working in a matrix environment required 
People management experience required 


Travel Requirements
Ability to travel up to 5% of the time. Travel to other CSPV sites or medical conferences as needed