Safety Physician - Lead
Full 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.
Must have Skill Set
PSUR
ICSR
Aggregate report
Safety Physician
Medical Review
Signal Detection
Skills Required
Safety Physician - Lead
Pharmaceuticals
MBBS, MD
Full Time, Permanent
Key Skills
- PSUR
- DSUR
- PV
- AGGREGATE
- SIGNAL
Other Information
GO/JC/2384/2026
Sangeetha Tamil
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