Senior Safety Associate III
3 weeks ago
Details for the position are as follows:
- 12 month contract with the possibility of extension or convertion.
- Location: Cambridge, MA - Hybrid
- Rate: $80-89hr depending on experience level.
Job Description:
- Will be responsible for supporting Global Case Management with ICSR quality review, controlled document updates and creation, training material edits and creation and associated tasks, and other case processing oversight activities as delegated. The Senior Safety Associate III supports the Case Processing Oversight and ICSR Processes and GCM Systems teams and is responsible for ensuring AE case processing is compliant with regulatory requirements and corporate and departmental procedures.
- Perform quality review of ICSRs
- Monitor case processing workflow for vendors and escalate cases at risk of missing timelines.
- Recording meeting minutes and team notes.
- Participate in testing and conference room pilots for Global Safety Database (GSD) upgrade project.
- Support other tasks as assigned by manager.
- Perform review and updates in controlled documents.
Required Skills:
- Bachelor's Degree in nursing, pharmacy, or other health care related profession or life sciences
- Must have a minimum of 5 years of PV experience
- Must have direct experience with end-to-end Case Processing (data entry and quality review) of both Clinical Trial and Post-marketing ICSRs
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