Safety aggregate report and analytics (sara) deliverables
Literature safety surveillance
Signal management activities
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, author responses to regulatory inquiries, and conduct ongoing literature safety surveillance.
Act as Signal Management Lead, setting up and implementing signaling strategies, performing signal detection and validation, and documenting signal tracking.
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) deliverables
literature safety surveillance
signal management activities
benefit risk management documents
regulatory agency inquiries
Good Pharmacovigilance Practice (GVP)
Nice-to-have
client interface and communication
mentorship and training
technology and innovation support
Key Requirements
Bachelor's Degree in Scientific or Healthcare discipline
2 - 3 years relevant work experience
Applicable global, regional, local regulatory requirements
Proven ability to meet strict deadlines
Excellent organizational and time management skills