Role & responsibilities
Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR for submission to local and other Health Authorities.
Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
Authoring of Signal Management Reports.
Performing literature search and validity check for the aggregate reports.
Reconciliation of relevant process trackers.
Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
Generation of Line Listings (LL) from safety database
Providing reliable support for high priority Ad-hoc activities.
Ensure all the reports are drafted within the allocated timelines.
Preferred candidate profile
Qualification - Pharma must.
Atleast 2+Years experience in Aggregate reporting is must.