PV Aggregate Reporting
MumbaiFull Time
PSUR
DSUR
PV
AGGREGATE
SIGNAL
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
PV Aggregate Reporting
Pharmaceuticals
Bachelor, Bachelor Degree
Full Time, Permanent
Key Skills
- PSUR
- DSUR
- PV
- AGGREGATE
- SIGNAL
Other Information
GO/JC/756/2025
Sangeetha Tamil
