Regulatory Medical Writing

Regulatory Medical Writing

Golden Opportunities Private Limited
Bengaluru / Bangalore
9 - 12 Years
Not Specified

Job Description

Authoring and reviewing of Aggregate Safety Reports: Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Report (PSUR) and Periodic Benefit Risk Evaluation Report (PBRER). Perform aggregate safety report related activities including literature search and line listing generation. Reviewing Safety update Tracker and Periodic Safety Reports Schedule tracker Ensure central archival of Pharmacovigilance related documents and maintenance of trackers Reviewing marketing authorization tracker Identifying re-training areas for the team based on peer QC findings.

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