- 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.