- BS in Nursing, Pharmacy, Healthcare or Lifesciences
- End-to-End Case Processing experience-hands on or oversight (data entry and quality review)
- Experience with both Clinical Trial and Post-marketing ICSRs
- Vendor Workflow Management
- Perform quality review of ICSRs
- Monitor case processing workflow for vendors and escalate cases at risk of missing timelines.
- Perform review and updates in controlled documents.
- 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.
- Bachelor's Degree in nursing, pharmacy, or other health care related profession or life sciences
- Must have direct experience with end-to-end Case Processing (data entry and quality review) of both Clinical Trial and Post-marketing ICSRs
- Advanced proficiency in Microsoft Office applications
- Exceptional organizational skills and attention to detail
- Ability to successfully and efficiently multi-task
- Excellent communication skills (written and verbal)
- Knowledge of common safety database systems
- Ability to work collaboratively in a team environment
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Senior Safety Associate - Cambridge, United States - Randstad Life Sciences US
Description
Sabr Associate III / Senior Safety Associate III
6 Month Initial Contract
Cambridge, MA (Hybrid)
Max PR: $57.58
MUST HAVE - Willing to work onsite Cambridge
SUMMARY
The Senior Safety Associate III 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.
ROLE
Education & Qualifications
