Posted:5 hours ago|
Platform:
Hybrid
Full Time
The role requires the individual to support Safety Signal Management by processing of signals of disproportionate reporting and by collation and review of signal evaluation reports.
Supporting aggregate reports by medical review of individual case safety reports for assigned periodic reports for various regions around the globe.
Details of the responsibilities:
1. Signal Management:
a. Processing and Evaluation
• Processing of Signals of Disproportionate Reporting (SDRs)
b. Report Generation
Drafting of molecule specific Signal Evaluation Reports
Drafting of molecule specific Signal Inputs for ADCOs / PBRERs/ PSURs/ Safety Evaluation Reports.
Quality review of data present in the Signal Evaluation Reports.
Quality review of data present in signal inputs for ADCOs /PBRERs/PSURs/Safety Evaluation Reports.
2. Aggregate Reports
a. Review of assigned individual case safety reports for periodic reports ensuring 100 % compliance as per applicable SOPs and guideline/Regulations.
3. Managing archival of assigned documents
4. Maintaining and Updating assigned Signal /PSUR Trackers
Sun Pharma
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