Found Description
Job Overview
Serve as principal owner of the SARA deliverable and have responsiblility for completion of the deliverable in compliance with all applicable service level agreements.
Essential Functions
• Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.
• Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings
• author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribu...
Serve as principal owner of the SARA deliverable and have responsiblility for completion of the deliverable in compliance with all applicable service level agreements.
Essential Functions
• Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects.
• Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings
• author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
• Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribu...