Job Description
Clinical Safety Scientist
The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for multiple clinical trials. The CSS may support collaboration with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.

QUALIFICATIONS & SKILLS

• Basic understanding of scientific and medical concepts
• Basic understanding of drug development
• Basic knowledge of GCP and ICH regulations98
• Ability to work as part of a cross-functional team
• Ability to identify and escalate problems and contribute to issue resolution
• Time management and organizational skills
• Strong communication skills with advanced oral and written English skills
• Advanced computer, database skills

EDUCATION REQUIREMENT:

• M.D. with minimum 1 year of clinical work experience in a patient care setting or 2 years relevant pharmaceutical, drug development, and/or drug safety experience.

• Intake of reportable safety event information from clinical trial investigator sites
• Review, manage and create individual case safety reports for each event
• Ensure that all information required for a clinically complete and accurate case is present
• Generate safety queries to the trial investigator sites to ensure case report accuracy and completeness
• Prioritize daily work to ensure all events are submitted for entry into the safety database within the established timeframes
• May collaborate with cross-functional colleagues as needed