Job Overview:
Oversee PV Program Operations; conduct regulatory research and provide regulatory intelligence to the PV Department and PV Clients.
(1.) To assist PV IT team in implementation of Argus Safety Database validation and user acceptance testing.
(2.) To ensure project deliverables are completed within agreed SLAs thereby maintaining effective client relationship, ensuring renewal of service and amending current service contracts as necessary.
(3.) To ensure timely processing of Individual Case Safety Reports for Global safety operations which include monitoring the adverse event (AE) case processing, AE reporting to regulatory authorities, global compliance, inspection readiness, quality management and pharmacovigilance training.
(4.) To establish Key Performance Indicators (KPIs) for the team and provide continuous coaching and guidance in order to upskill the team members.
(5.) To monitor processes, workflow, identify areas of improvement and implement process improvement initiatives along with other stakeholders.
C3i Solutions is an Equal Opportunity Employer - EOE, M/F, D/V.
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Job Type: Full-time
Pay: $80,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Schedule:
Willingness to travel:
Work Location: Remote