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2.0 - 4.0 years

3 - 12 Lacs

noida, uttar pradesh, india

On-site

Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection. Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER), and Clinical Expert Statements., Publishing, distribution, archiving and submission of safety reports. Preparation of Signal detection reports, including EVDAS screening if applicable. Preparation of SARs (Signal Assessment Reports). Writing Risk Management Plans (RMPs). Identifying safety concerns and providing advice with regard to future ri...

Posted 2 days ago

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