About the role

To advance the development of cutting-edge antibody therapies, the full-time salaried State Licensed Drug Safety Physician will manage Individual Case Safety Report (ICSR) reviews, oversee safety monitoring, and provide medical safety input for clinical trial documents in a remote working environment.
Key Responsibilities: Perform triage and medical review of ICSRs and oversee cases for expedited safety reporting Lead cross-functional medical review discussions and participate in the preparation of aggregate safety review documents Collaborate on safety data review and participate in safety management team meetings
Required Qualifications: MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience Degree in epidemiology or extensive knowledge in Epidemiology/Pharmacoepidemiology preferred Proficiency in Argus global safety database and medical review activities Experience in safety surveillance and signal detection activities Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.)

Matching similar jobs

JOB OVERVIEW

Experience level

Senior

Location

Denver, CO

Occupation

Physicians, All Other

Industry

Offices of Physicians (except Mental Health Specialists)

Posted

yesterday

Tired of running searches?

Rank the roles you'd take once, and matches like these arrive on their own.

CREATE PROFILE