Serve as principal owner of SARA deliverables, ensuring completion in compliance with all applicable service level agreements
Job Summary
Serve as principal owner of SARA deliverables, ensuring completion in compliance with all applicable service level agreements.
Lead, author, and finalize aggregate reports, conduct ongoing literature safety surveillance, and act as Signal Management Lead on projects.
Interface with clients and internal functional groups, participate in audits, and contribute to departmental goals while adhering to SOPs and training requirements.
Matching Summary
Serve as principal owner of SARA deliverables, ensuring completion in compliance with all applicable service level agreements.
Skills & Requirements
Must-have
Safety Aggregate Report and Analytics (SARA)
aggregate reports
literature safety surveillance
signal management
regulatory agency inquiries
Nice-to-have
mentorship and training
technology / innovation activities
client interface
internal and external audits
Key Requirements
Bachelor's Degree in Scientific or Healthcare discipline
2 - 3 years relevant work experience
Knowledge of Lifecycle Safety services and processes
Understanding of applicable global regulatory requirements (GCP, GVP, ICH)
Ability to meet strict deadlines and manage competing priorities