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PV Aggregate Reporting

PV Aggregate Reporting

Golden Opportunities Pvt Ltd

5 - 8 years

20 - 25 Lacs

mumbai hyderabad

Posted:None| Platform:

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Skills Required

psur pv dsur signal aggregate medical writing arisg itr regulatory drug safety scientific writing clinical data management pharmacovigilance risk management plan drug as aggregate reporting rmp pbrer case processing clinical research argus meddra clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preparation and review of aggregate reports such as Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plans (RMPs), Addendum to Clinical Overview (ADCO) etc
Co-ordination with various stakeholders to gather data required for Aggregate reports
Work closely with service providers and resolve their queries
Co-ordinate with various stakeholders internal and external required for the completion reports
Preparation and review of Query responses from Regulatory Authority

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