9 March, 2022
Job title: PV Associate III
Job location: Bangalore(work from office)
Years of work experience: 8+ years in PV
· Preparation of periodic safety reports, PADERs, for the USA regulatory agency (FDA).
· Medical review of PADERs.
· Quality control of PADERs.
· Administrator, Quality Approver, Submitter, Writer, MD, QC role in the TrackWise system.
· Maintenance of the TrackWise system.
· Literature review for NDA Annual Reports submitted to the FDA.
· Preparation of Standard Operating Procedure (SOP) documents, Working Instructions (WI), and Manuals.
· Inspection/audit interviewee.
· Other tasks assigned by the direct manager.
Kindly apply on the below job link if its matching your skillsets: