Aggregate Reporting_Deputy Manager/ Assistant Manager
MumbaiFull Time
PADERS
PBRERS
ADCO
RMPS
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
Skills Required
Aggregate Reporting_Deputy Manager/ Assistant Manager
Pharma and Healthcare
Pharmaceutical
Full Time, Permanent
Life Sciences and Pharma
Key Skills
- PADERS
- PBRERS
- ADCO
- RMPS
Other Information
GO/JC/19711/2024
Kalaiyarasan
