Freyr Solutions Hyderabad Pharmaco -vigilance Jobs | Aggregate report Writing Apply Now
Department - Drug Safety (PV)
Designation -Associate
Education - Any life science
No. of Position - 1
Exp: 1- 2 years
Skills - Aggregate report Writing, RMP
Work location
India- Hyderabad, level 4, Building No. H-08, Phoenix SEZ, HITEC City 2, Gachibowli, Hyderabad, Telangana, India- 500081
Description
:
– To draft/review aggregate reports like Periodic Benefit-Risk Evaluation Report (PBRERs),
Description
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Periodic Safety Update Report (PSURs), periodic Adverse Drug experience Reports (PADERs),
Description
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Canada Annual Safety Reports (CASRs), Addendum Reports (ARs) and Summary Bridging Reports (SBRs).
Description
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– To draft/review Safety Reports like Risk management plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS).
Description
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– To draft/review safety assessment reports(SARs).
– To evaluate the benefit-risk profile of the product.
Description
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– Supporting the team in improving the process.
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