Drug Safety Associate

Location: 
Waltham, MA or Remote
Position Summary: 

Job Description

Drug Safety Associate

Summary of Position:
Maintaining high quality and accuracy in the identification and reporting of Drug Safety events is a critical function within Corrona. This role supports collection, tracking, safety data management, and ongoing coordination and maintenance of Corrona’s case adjudication program (e.g. preparing adjudication packets for adverse events reported by sites, helping to coordinate assignments and related work group activities). Quality Control (QC) of safety data are to be achieved in accordance with Company SOPs, and relevant regulatory standards. This role provides critical support to multiple team members and company priorities.

Essential Functions:
- Tracking details for incoming Adverse Event reports
- Coordination, communication and triage of reportable cases
- Tracking site follow-up action items for Targeted Adverse Events (e.g. missing, incomplete TAEs)
- Tracking Targeted Adverse Events by adjudication status
- Data entry support for Targeted Adverse Events and adjudication results, as needed
- Screening of received questionnaires for completeness, in accordance with internal guidance
- Verification, review and tracking of supporting documents for incoming Targeted Adverse Events
- Creation of electronic backup files, adjudication packets for completely reported events
- Prepare case adjudication packets for shipment to adjudication team(s), per specifications
- Site data clarification requests for missing or discordant safety data
- Support of site QC cycles to promote timely resolution of open site action items
- Implementation support for software integration projects requiring daily use of multiple applications
- Data entry, assessment, and consolidation to complete case migration for software implementations
- Core member of Drug Safety Team supporting a variety of working groups and deliverable types
- Organizing and scheduling team meetings, as needed
- Ongoing professional training or education appropriate to role, as assigned
- Participation in team meetings and conference calls, as assigned
- Participation in assigned work groups or task forces for priority PV Team work streams or initiatives
- Other duties as assigned

Education and Experience:
- Highly detail-oriented with excellent time management skills
- Strong written and verbal communication skills
- Proficiency in MS Office: Word, PowerPoint, Excel, Outlook
- Completion of GCP training (provided by Corrona)
- Medical Terminology (training support available)
- Training and/or experience in a related discipline (e.g. research, clinical training) preferred

Work Environment:
- Remote position
- Must be able to remain in a stationary position 50%

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Position Details
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