Ensure compliance (quality, procedures, regulations, timeliness, consistency) of aggregate reports, Signal management & all EU activities.
Facilitate safety monitoring by optimising scientific quality documentation & data entry of safety case reports including spontaneous litigation reports.
Management of ICSR activities as per respective regulatory requirements including safety data accuracy in safety databases.
Responsible for partner/vendor audit and communication for all PV activity.
Preparation and review of SDEA.
Handling of RMP program in line with innovator for UK & EMA.
Management of XEVMPD & SPOR databases with timely update safety variation in line with Art. 57 guideline.
Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years of Experience"