Get Our FREE Industry eNewsletter

Drug Safety Assistant

InterMune, Inc.

Brisbane, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Drug Safety Assistant will assist in completion of projects and assignments for the Drug Safety Risk Management department.

Responsibilities include:  
- Perform intake of adverse event data including data entry and case file  creation, including initial case review and identification using IRT and ARISg database
- Perform pre-initiation triage of monthly line listing cases
- Perform intake, follow-up, and distribution of case queries using IRT and ARISg databases
- Monitor SafetyOps inbox to ensure the follow-up and processing of all received items in an expeditious manner
- Perform reconciliation of adverse event reports with partners, CROs, and other departments
- Perform submission of expedited and reportable adverse event reports
- Perform electronic and hard copy document management, retrieval, and archiving
- Perform document formatting and editing as requested
- Maintain departmental secure filing room
- Assist in the compilation of aggregate reports and other ad hoc reports as required


- Bachelor’s degree
- The ideal candidate should have a general understanding of drug development, drug safety reporting, as well as medical communications practices, and an appreciation for the importance of regulatory compliance
- Strong computer, including Microsoft Office skills, and database skills
- Strong organizational, oral/written communication and project management skills
- Requires strong attention to detail and a high commitment to the quality of all projects and accountability for deliverables
- Demonstrated ability to manage multiple projects and ability to prioritize
- Ability to solve complex problems and suggest creative solutions
- Proactive, positive approach to work projects and constructive, supportive interactions with colleagues

By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.