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Drug Safety Assistant

InterMune, Inc.

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Location:
Brisbane, CA
Posted Date:
7/10/2014
Position Type:
Full time
Job Code:
DSRM13252
Salary:
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

Requirements

- 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

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